Constipation-predominant IBS (IBS-C)Phase 2NCT02144753
Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)
A Phase 2 study testing NTX-1 and psyllium (15 g) in people with Constipation-predominant IBS (IBS-C), run by Nutrabiotix, LLC at 1 site in United States.
Trial summary
The objective of this Phase II trial is to test the NTX-1 Fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation-predominant IBS (IBS-C)
- What is being tested?
- NTX-1 and psyllium (15 g)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-75
- Have recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months
- Have at least 2 of the following in the last 6 months:
- Improvement of abdominal pain or discomfort with defecation
- Onset of abdominal pain or discomfort associated with change in frequency of stool
- Onset of abdominal pain or discomfort associated with a change in form/appearance of stool
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- Symptom onset at least 6 months prior to screening date
- Willing to take study supplement three times a day and willing to comply with all study procedures (i.e. swallow capsules)
- Willing to stop taking over-the-counter laxatives after the 2 week screening period (Ex: ex-lax, senna, miralax, milk of magnesia)
- Abdominal bloating/discomfort/pain (if either a, b, OR c is positive, then this meets the criteria for #7)
- A weekly average of worst abdominal bloating score of ≥ 3 during the screening period on a 0-10 numeric rating scale
- A weekly average of worst abdominal discomfort score of ≥ 3 during the screening period on a 0-10 numeric rating scale
- A weekly average of worst abdominal pain score of ≥ 3 during the screening period on a 0-10 numeric rating scale
- Bowel movements/stool consistency (if either a OR b is positive, then this meets the criteria for #8)
- Less than 3 spontaneous complete BM (SCBM) per week. (SCBM is defined as a BM occurring in the absence of a laxative that is associated with a sense of complete evacuation)
- Stool consistency of 1-2 on Bristol scale at least twice a week OR >25% of BM for the week
Who cannot join
- Abnormalities in CBC (Hgb<12 g/dL, platelet count<100000, WBC<4000 or >10000)
- Abnormal liver function tests (ALT, AST, alkaline phosphatase, or bilirubin >1.5 times normal range)
- Abnormal renal function tests (BUN or creatinine >1.5 times normal range)
- Low serum albumin (<3 g/dL)
- Uncontrolled thyroid disease as evident from abnormal TSH level
- High CRP (> 5), except those evaluated for IBD and IBD is ruled out through colonoscopy, CT or additional tests
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- Insulin-requiring and/or poorly controlled diabetes (well-controlled diabetics with HbA1c <7 may be enrolled)
- Patient history of GI diseases (except for hemorrhoids or occasional (<3 times a week) heartburn)
- Inflammatory bowel disease (Ex: ulcerative colitis, crohn's disease, any colitis)
- Celiac disease
- Colonic inertia (lazy/slow colon resulting in surgery, resection or daily laxatives)
- Diverticular stricture (narrowing of the colon)
- Antibiotic use within last 4 weeks
- Severe uncontrolled hypertension
- Significant uncompensated cardiac or respiratory diseases (defined as requiring daily medication for management of their diseases (Ex: on oxygen or can't walk))
- Prior extensive intestinal resection
- History of psychiatric hospitalization OR suicide attempt in the last 5 years
- Drug and/or alcohol abuse
- Plan to have a major change of their dietary habit during the following 5 months
- Drug induced constipation (Ex: opiates)
- Pregnant or lactating
- Use of narcotic medications (pain killers, Ex: hydrocodone, methadone, morphine, oxycodone or tramadol) or anticoagulant/antiplatelet agents (ex: heparin, warfarin , dabigitran., Coumadin)
- If the subject is older than 50 years of age, subjects who have not had a colonoscopy within last 7 years or CT colonography within last 5 years to rule out colon cancer
- Alarm symptoms of colon cancer such as:
- Weight loss (>10% unintentional loss of body weight in last 6 months)
- Blood in the stool (except for clearly documented hemorrhoidal bleed OR colonoscopy excluding colon cancer within the last year for blood in the stool)
- Anemia (without a full work-up, including a colonoscopy or other tests deemed important)
- Continued chronic and daily use of prescription laxatives (Ex: Amitiza or Linzess/ linaclotide in the last month)
- Loose or watery stools > than 3 times per week
- History of fecal impaction requiring disimpaction in the last 3 months
- History of laxative abuse (Ex: eating disorders)
- Use of medications that affect gastrointestinal motility (i.e. resolor, domperidone, reglan, cisapride, anticolonergic drugs, tricyclic antidepressant [Ex: Amitriptyline, Amoxapine, anafranil, asendin, elavil, norpramin/desipramine, doxepin, pamelor/nortriptyline, sinequan, surmontil/trimipramine, tofranil/imipramine or vivactil/protriptyline]) SSRI's are OK
- Documented untreated pelvic floor dysfunction
- Colonic organic diseases such as:
- Current colonic cancer or strictures
- Connective tissue disease (ex: scleroderma, lupus)
- Other neurological disorders leading to chronic constipation (Ex: Parkinson's or multiple sclerosis)
- Dietary intake exceptionally high in plant-based, high fiber foods, including those following a strict vegetarian diet (high fiber foods: fruits, vegetables, beans, whole grains, fortified foods)
- Consumption of probiotics, prebiotics, or synbiotics without an appropriate 2-week washout period (Ex: Activia, FiberOne products, probiotics supplements such as Align, Pearls, or fiber/prebiotic supplements such as Metamucil, Benefiber, Citrucel, Fiber Choice, Fiber Powder)
- Intention of using fiber products during the study (other than the study supplement)
- Known food allergies or hypersensitivities (Ex: the components of psyllium or NTX-1 (corn))
- Have a colonoscopy done within the next 5 months
- Exclusion- Screening Diary 32. Use of laxatives more than twice in the screening period (The following are the ONLY laxatives the subject is allowed to use during the screening period: Ex-lax, senna, miralax and milk of magnesia) 33. Have not completed 11 out of 14 days of symptoms diary at screening 34. Have an average daily IBS-C global symptom score of <2 in the screening period 35. Average Bristol stool scale of more than 4 within the screening period 36. Loose or watery stools with Bristol stool scale of 5 or greater for a total of 6 or more days during the screening period 37. Use of fiber products during the screening period
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The objective of this Phase II trial is to test the NTX-1 Fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. The investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e has less side effects) and is more effective than psyllium (the most commonly used fiber in the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA levels.
Read the detailed description
The investigators will conduct an 18-week (2-week initial run-in phase, 12-week treatment phase, and 4-week follow up phase), 2-arm, randomized, double-blind, controlled Phase 2 trial in 120 subjects with IBS-C. A 2-week run in will be completed in order to ensure the stability of baseline symptom scores and to ensure that all study subjects have the required symptom severity to fulfill the inclusion criteria before randomization and beginning the treatment. The investigators selected a 12-week treatment phase because of the adequacy of this length of time to clinically see the impact of fiber supplementation (as seen in the investigators Phase I trial), and because of the 12-week duration requirement of the FDA for all therapeutic intervention/agents for treatment of IBS. The 4-week follow up phase is to determine the sustainability of the effects of therapy and to obtain further safety data.Potential study subjects will be identified though the Rush University Medical Center (RUMC) clinical databases; advertisements on the RUMC clinical trials and GI websites, RUMC Facebook and other social media sites; and IRB approved flyers placed in the GI clinic and throughout the medical center. All potential candidates will be interviewed on the phone by a clinical coordinator using a structured checklist, at which time the study requirements will also be explained. Subjects will be asked for food allergies, including artificial sweeteners such as sucralose and ascelfame K. Subjects will also be informed that the fiber is made out of corn or psyllium and not other grains. However, it can't be guaranteed that it is free of other food allergy-related contaminants. Also, subjects will be asked to limit intake of foods containing more than 3 grams of prebiotics. A list of these foods will be provided.
Those who are eligible and are willing to participate will be invited for the first study visit. Five visits will be required from each subject.
Visit 1: After the subject has reviewed and signed the informed consent form, the investigators will check to see if they are eligible for this study by a physical exam, questionnaires and a blood test. A physician or their assistant will do a physical exam and take the subjects vitals (such as height, weight, waist circumference and blood pressure).
The Subject Information Form will be an administered questionnaire related to their health, disease, and their family medical history. They will then have 2½ tablespoons of blood drawn by a certified nurse or medical assistant. They will be reminded in advance to fast 12 hours prior to their research visit. The blood tests include: CBC, CMP, CRP, TSH, INR, fasting lipid profile and HbA1c. The subject will be given a 3-day food diary and a 14-day IBS symptom diary to complete before their next visit. They will also be provided with stool collection supplies and instructions to take home. When blood test results are available, those who do not fit the criteria will be called within 7 days after Visit 1 stating that they are ineligible. Among these blood tests, the fasting lipid profile results will be given to the subject after their participation in the study and after completion of the study. The rest of the results will be given to the subject at their next visit. If they continue to be a candidate in this study based on blood results, the potential subjects will fill out the 3-day food diary, continue to fill out the 14-day IBS symptom diary, and complete the stool collection the day before or the morning of Visit 2. The subject will be advised to not keep the stool at room temperature longer than 5 hours. If they anticipate it to be longer than 5 hours before their visit time, then the stool will be kept in the freezer. Both of the diaries and the stool sample are to be brought to Visit 2, which is 2 weeks after their Visit 1. Visit 1 will be about 3 hours in length.
Visit 2: The subject will give the study coordinator their 3-day food diary, 14-day IBS symptom diary, and stool sample. They will provide the date of stool collection, as well as the method of storing the sample. The physician will review their 14-day IBS symptom diary and confirm their eligibility. If they continue to be eligible, the physician will do a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out a series of questionnaires relating to their diet (VioScreen Food Frequency Questionnaire), IBS symptoms (IBS-Quality of Life questionnaire [IBS-QoL] and IBS Questionnaire by Whorwell and Francis), sleeping/circadian patterns (2 NIH sleep questionnaires, Munich Chronotype Questionnaire, Lark/Hummingbird/Owl questionnaire, food timing questionnaire), the Expectancy and Credibility Questionnaire, and the 34-item tool asking about their GI symptoms and severity. The subject will then be randomized into one of the two groups. Depending on which group they are randomized to, they will be provided with a 6-week supply of NTX-1 OR psyllium fiber products in an identical appearing sachet along with instructions for taking the fiber. They will be provided with a 3-day food diary and a daily and weekly IBS symptom diary to fill out prior to Visit 3. This visit will be about 3 hours in length. The next visit will be 6 weeks after Visit 2.
Visit 3: The subject will give the study coordinator their 3-day food diary, the daily and weekly IBS symptom diary, and any excess fiber product. The physician will review their IBS symptom diary and ensure there are no significant adverse events. The physician will do a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out a series of questionnaires relating to their IBS symptoms (IBS-Quality of Life questionnaire (IBS-QoL) and IBS Questionnaire by Whorwell and Francis), sleeping/circadian patterns (2 NIH sleep questionnaires, Munich Chronotype Questionnaire, Lark/Hummingbird/Owl questionnaire, food timing questionnaire), the Expectancy and Credibility Questionnaire, and the 34-item tool asking about their GI symptoms and severity. Next, they will have 2 tablespoons of blood drawn by a certified nurse or medical assistant. The following blood tests will be done: CBC, CMP and CRP. The subject will be reminded in advance to fast 12 hours prior to their research visit. A copy of their blood test results will be given to them at their next visit. Next, they will be given another 6-week supply of the fiber product, the 3-day food diary, a daily and weekly IBS symptom diary to fill out prior to Visit 4 and stool collection supplies. They are asked to collect stool as previously indicated and bring the stool to Visit 4; handling will be identical to previous visit. This visit will be about 2 hours in length. The next visit will be 6 weeks after their Visit 3.
Visit 4: The subject will give the study coordinator their 3-day food diary, the daily and weekly IBS symptom diary, and any excess fiber product. The physician will review their IBS symptom diary and ensure there are no significant adverse events. The physician will complete a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out a series of questionnaires relating to their diet (VioScreen Food Frequency Questionnaire), IBS symptoms (IBS-Quality of Life questionnaire (IBS-QoL) and IBS Questionnaire by Whorwell and Francis), sleeping/circadian patterns (2 NIH sleep questionnaires, Munich Chronotype Questionnaire, Lark/Hummingbird/Owl questionnaire, food timing questionnaire), the Expectancy and Credibility Questionnaire, and the 34-item tool asking about their GI symptoms and severity. They will then have 2½ tablespoons of blood drawn by a certified nurse or medical assistant. Subjects will be reminded in advance to fast 12 hours prior to their research visit. The blood tests include: CBC, CMP, CRP, TSH, INR, fasting lipid profile and HbA1c. Among these blood tests, the fasting lipid profile results will be given to the subject after the completion of the study. The rest of the results will be given to the subject at their next visit. They will be provided with a 3-day food diary and a daily and weekly IBS symptom diary to fill out prior to Visit 5. Visit 4 will be about 3 hours in length. The next visit will be 4 weeks after their fourth visit, which is the subjects' last visit.
Visit 5: The subject will give the study coordinator their 3-day food diary and the daily and weekly IBS symptom diary. The physician will review their IBS symptom diary and ensure there are no significant adverse events. The physician will do a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out questionnaires relating to their IBS symptoms (IBS-Quality of Life questionnaire (IBS-QoL) and IBS Questionnaire by Whorwell and Francis) and the 34-item tool asking about their GI symptoms and severity. Next, they will have 2 tablespoons of blood drawn by a certified nurse or medical assistant. Subjects will have been reminded in advance to fast 12 hours prior to their research visit. The following blood tests will be done: CBC and CMP. A copy of their blood test results, including the two fasting lipid profile tests, will be given to the subject via e-mail or mail. This visit will be about 2 hours in length.
- Conditions
- Constipation-predominant IBS (IBS-C)
- Being tested
- NTX-1, psyllium (15 g)
- Keywords
- IBS-C, Constipation, IBS
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX-1Dietary supplement
Also called Nutrabiotix (18g)
Investigational NTX-1 fiber to be taken as three (6g each) packets of the fiber per day, one 8g packet in the morning (one hour before eating breakfast) and the other two 8g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.
psyllium (15 g)Drug
Also called psyllium
Psyllium (an over-the-counter fiber) to be taken as three (5g each) packets of the fiber per day, one 5g packet in the morning (one hour before eating breakfast) and the other two 5g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.
| Study group | Role | What they receive |
|---|---|---|
| NTX-1 | Experimental | NTX-1 (18 g) Receives: Dietary Supplement: NTX-1 |
| Psyllium | Active comparator | psyllium (15 g) Receives: Drug: psyllium (15 g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite improvement in the following three areas: IBS global improvement score on the Likert Scale, frequency & consistency of stools, & severity of abdominal pain, discomfort and bloating
Compare the effects of NTX-1 (18 grams) against psyllium (15 grams) on IBS global improvement score, frequency \& consistency of stools, \& severity of abdominal pain, discomfort and bloating in patients with IBS-C (as defined by the Rome III criteria).
Measured: up to 14 months
Secondary outcomes (1)
Determine side effects of NTX-1
The following scales will be used to measure side effects experienced by subjects: (1) Frequency (# of total BM/week) and consistency of stool (Bristol stool scale); (2) Severity of abdominal pain (11 point numeric scale from 0-10); (3) Severity of bloating (11 point numeric scale from 0-10); (4) Severity of abdominal discomfort (11 point numeric scale from 0-10); (5) Difficulty with defecation (i.e. straining) (11 point numeric scale from 0-10); (6) Frequency (number of SCBMs/week and SBMs/week), (7) Global IBS symptom score from 0-4 on a 5 point numeric scale/week; (8) Adequate relief from IBS symptoms (yes, no)
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Per DSMB, study fiber had given subjects more adverse events and made their IBS symptoms worse than the psyllium group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation-predominant IBS (IBS-C)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrabiotix, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Responsible party
- Sponsor
- Investigators
- Ece Mutlu, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144753
- Sponsor's protocol ID
- SBIR-2013-NTX
- Status last verified
- Apr 2016
- First submitted
- 15 May 2014
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)
- ClinicalTrials.gov ID
- NCT02144753
- Acronym / sponsor ID
- SBIR-2013-NTX
- Conditions
- Constipation-predominant IBS (IBS-C)
- Keywords
- IBS-C, Constipation, IBS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per DSMB, study fiber had given subjects more adverse events and made their IBS symptoms worse than the psyllium group.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nutrabiotix, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Phase II trial is to test the NTX-1 Fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. The investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e has less side effects) and is more effective than psyllium (the most commonly used fiber in the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA levels.
Detailed description
The investigators will conduct an 18-week (2-week initial run-in phase, 12-week treatment phase, and 4-week follow up phase), 2-arm, randomized, double-blind, controlled Phase 2 trial in 120 subjects with IBS-C. A 2-week run in will be completed in order to ensure the stability of baseline symptom scores and to ensure that all study subjects have the required symptom severity to fulfill the inclusion criteria before randomization and beginning the treatment. The investigators selected a 12-week treatment phase because of the adequacy of this length of time to clinically see the impact of fiber supplementation (as seen in the investigators Phase I trial), and because of the 12-week duration requirement of the FDA for all therapeutic intervention/agents for treatment of IBS. The 4-week follow up phase is to determine the sustainability of the effects of therapy and to obtain further safety data.Potential study subjects will be identified though the Rush University Medical Center (RUMC) clinical databases; advertisements on the RUMC clinical trials and GI websites, RUMC Facebook and other social media sites; and IRB approved flyers placed in the GI clinic and throughout the medical center. All potential candidates will be interviewed on the phone by a clinical coordinator using a structured checklist, at which time the study requirements will also be explained. Subjects will be asked for food allergies, including artificial sweeteners such as sucralose and ascelfame K. Subjects will also be informed that the fiber is made out of corn or psyllium and not other grains. However, it can't be guaranteed that it is free of other food allergy-related contaminants. Also, subjects will be asked to limit intake of foods containing more than 3 grams of prebiotics. A list of these foods will be provided.
Those who are eligible and are willing to participate will be invited for the first study visit. Five visits will be required from each subject.
Visit 1: After the subject has reviewed and signed the informed consent form, the investigators will check to see if they are eligible for this study by a physical exam, questionnaires and a blood test. A physician or their assistant will do a physical exam and take the subjects vitals (such as height, weight, waist circumference and blood pressure).
The Subject Information Form will be an administered questionnaire related to their health, disease, and their family medical history. They will then have 2½ tablespoons of blood drawn by a certified nurse or medical assistant. They will be reminded in advance to fast 12 hours prior to their research visit. The blood tests include: CBC, CMP, CRP, TSH, INR, fasting lipid profile and HbA1c. The subject will be given a 3-day food diary and a 14-day IBS symptom diary to complete before their next visit. They will also be provided with stool collection supplies and instructions to take home. When blood test results are available, those who do not fit the criteria will be called within 7 days after Visit 1 stating that they are ineligible. Among these blood tests, the fasting lipid profile results will be given to the subject after their participation in the study and after completion of the study. The rest of the results will be given to the subject at their next visit. If they continue to be a candidate in this study based on blood results, the potential subjects will fill out the 3-day food diary, continue to fill out the 14-day IBS symptom diary, and complete the stool collection the day before or the morning of Visit 2. The subject will be advised to not keep the stool at room temperature longer than 5 hours. If they anticipate it to be longer than 5 hours before their visit time, then the stool will be kept in the freezer. Both of the diaries and the stool sample are to be brought to Visit 2, which is 2 weeks after their Visit 1. Visit 1 will be about 3 hours in length.
Visit 2: The subject will give the study coordinator their 3-day food diary, 14-day IBS symptom diary, and stool sample. They will provide the date of stool collection, as well as the method of storing the sample. The physician will review their 14-day IBS symptom diary and confirm their eligibility. If they continue to be eligible, the physician will do a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out a series of questionnaires relating to their diet (VioScreen Food Frequency Questionnaire), IBS symptoms (IBS-Quality of Life questionnaire [IBS-QoL] and IBS Questionnaire by Whorwell and Francis), sleeping/circadian patterns (2 NIH sleep questionnaires, Munich Chronotype Questionnaire, Lark/Hummingbird/Owl questionnaire, food timing questionnaire), the Expectancy and Credibility Questionnaire, and the 34-item tool asking about their GI symptoms and severity. The subject will then be randomized into one of the two groups. Depending on which group they are randomized to, they will be provided with a 6-week supply of NTX-1 OR psyllium fiber products in an identical appearing sachet along with instructions for taking the fiber. They will be provided with a 3-day food diary and a daily and weekly IBS symptom diary to fill out prior to Visit 3. This visit will be about 3 hours in length. The next visit will be 6 weeks after Visit 2.
Visit 3: The subject will give the study coordinator their 3-day food diary, the daily and weekly IBS symptom diary, and any excess fiber product. The physician will review their IBS symptom diary and ensure there are no significant adverse events. The physician will do a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out a series of questionnaires relating to their IBS symptoms (IBS-Quality of Life questionnaire (IBS-QoL) and IBS Questionnaire by Whorwell and Francis), sleeping/circadian patterns (2 NIH sleep questionnaires, Munich Chronotype Questionnaire, Lark/Hummingbird/Owl questionnaire, food timing questionnaire), the Expectancy and Credibility Questionnaire, and the 34-item tool asking about their GI symptoms and severity. Next, they will have 2 tablespoons of blood drawn by a certified nurse or medical assistant. The following blood tests will be done: CBC, CMP and CRP. The subject will be reminded in advance to fast 12 hours prior to their research visit. A copy of their blood test results will be given to them at their next visit. Next, they will be given another 6-week supply of the fiber product, the 3-day food diary, a daily and weekly IBS symptom diary to fill out prior to Visit 4 and stool collection supplies. They are asked to collect stool as previously indicated and bring the stool to Visit 4; handling will be identical to previous visit. This visit will be about 2 hours in length. The next visit will be 6 weeks after their Visit 3.
Visit 4: The subject will give the study coordinator their 3-day food diary, the daily and weekly IBS symptom diary, and any excess fiber product. The physician will review their IBS symptom diary and ensure there are no significant adverse events. The physician will complete a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out a series of questionnaires relating to their diet (VioScreen Food Frequency Questionnaire), IBS symptoms (IBS-Quality of Life questionnaire (IBS-QoL) and IBS Questionnaire by Whorwell and Francis), sleeping/circadian patterns (2 NIH sleep questionnaires, Munich Chronotype Questionnaire, Lark/Hummingbird/Owl questionnaire, food timing questionnaire), the Expectancy and Credibility Questionnaire, and the 34-item tool asking about their GI symptoms and severity. They will then have 2½ tablespoons of blood drawn by a certified nurse or medical assistant. Subjects will be reminded in advance to fast 12 hours prior to their research visit. The blood tests include: CBC, CMP, CRP, TSH, INR, fasting lipid profile and HbA1c. Among these blood tests, the fasting lipid profile results will be given to the subject after the completion of the study. The rest of the results will be given to the subject at their next visit. They will be provided with a 3-day food diary and a daily and weekly IBS symptom diary to fill out prior to Visit 5. Visit 4 will be about 3 hours in length. The next visit will be 4 weeks after their fourth visit, which is the subjects' last visit.
Visit 5: The subject will give the study coordinator their 3-day food diary and the daily and weekly IBS symptom diary. The physician will review their IBS symptom diary and ensure there are no significant adverse events. The physician will do a physical exam and take their vitals (such as weight, waist circumference and blood pressure). The subject will then be asked to fill out questionnaires relating to their IBS symptoms (IBS-Quality of Life questionnaire (IBS-QoL) and IBS Questionnaire by Whorwell and Francis) and the 34-item tool asking about their GI symptoms and severity. Next, they will have 2 tablespoons of blood drawn by a certified nurse or medical assistant. Subjects will have been reminded in advance to fast 12 hours prior to their research visit. The following blood tests will be done: CBC and CMP. A copy of their blood test results, including the two fasting lipid profile tests, will be given to the subject via e-mail or mail. This visit will be about 2 hours in length.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTX-1 | Experimental | Dietary Supplement: NTX-1NTX-1 (18 g) |
| Psyllium | Active comparator | Drug: psyllium (15 g)psyllium (15 g) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Between the ages of 18-75
- Have recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months
- Have at least 2 of the following in the last 6 months:
- Symptom onset at least 6 months prior to screening date
- Willing to take study supplement three times a day and willing to comply with all study procedures (i.e. swallow capsules)
Key exclusion criteria (43 listed)
- Abnormalities in CBC (Hgb<12 g/dL, platelet count<100000, WBC<4000 or >10000)
- Abnormal liver function tests (ALT, AST, alkaline phosphatase, or bilirubin >1.5 times normal range)
- Abnormal renal function tests (BUN or creatinine >1.5 times normal range)
- Low serum albumin (<3 g/dL)
- Uncontrolled thyroid disease as evident from abnormal TSH level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX-1Also: Nutrabiotix (18g)Investigational NTX-1 fiber to be taken as three (6g each) packets of the fiber per day, one 8g packet in the morning (one hour before eating breakfast) and the other two 8g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose. | Dietary supplement | NTX-1 |
| psyllium (15 g)Also: psylliumPsyllium (an over-the-counter fiber) to be taken as three (5g each) packets of the fiber per day, one 5g packet in the morning (one hour before eating breakfast) and the other two 5g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose. | Drug | Psyllium |
Primary outcome
Composite improvement in the following three areas: IBS global improvement score on the Likert Scale, frequency & consistency of stools, & severity of abdominal pain, discomfort and bloating
Time frame: up to 14 months
Compare the effects of NTX-1 (18 grams) against psyllium (15 grams) on IBS global improvement score, frequency \& consistency of stools, \& severity of abdominal pain, discomfort and bloating in patients with IBS-C (as defined by the Rome III criteria).
1 secondary outcome
Determine side effects of NTX-1
Time frame: up to 14 months
Results and safety
The study was stopped early (reason given: Per DSMB, study fiber had given subjects more adverse events and made their IBS symptoms worse than the psyllium group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ece Mutlu, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTX-1 and psyllium (15 g) in people with Constipation-predominant IBS (IBS-C), run by Nutrabiotix, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per DSMB, study fiber had given subjects more adverse events and made their IBS symptoms worse than the psyllium group.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite improvement in the following three areas: IBS global improvement score on the Likert Scale, frequency & consistency of stools, & severity of abdominal pain, discomfort and bloating (time frame: up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.