IBS - Irritable Bowel SyndromeNCT03983434
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
A study testing Inulin in people with IBS - Irritable Bowel Syndrome, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Inulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
- Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.
Who cannot join
- Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT > 2.0x the upper limit of normal
- Prior radiation therapy of the abdomen or abdominal surgeries except for C-section, tubal ligation, vaginal hysterectomy and appendectomy or cholecystectomy, > 6 months prior to study initiation.
- Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed.
- Any females who are pregnant or trying to become pregnant or breast-feeding
- Antibiotic usage within 3 months prior to study participation
- Prebiotic or probiotic usage within the 2 weeks prior to study initiation
- Regular use of tobacco products within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge
The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.
Read the detailed description
The Study involves 3 visits and will in include 3 types of subjects - those who have irritable bowel syndrome (IBS) with constipation (IBS-C), IBS with diarrhea (IBS-D) and those who have no IBS symptoms or diagnosis.
Visit 1
- Volunteers will read and sign this informed consent after all questions about the study have been answered
- This is a screening visit and we may determine that volunteers ineligible to continue to participate in the study.
- Volunteers will have a medical history taken including demographics, history of symptoms and illness
- Volunteers will be asked about all medications
- A physical exam will be performed by the physician.
- Vital signs will be measured.
- Urine Pregnancy test may be done for woman in the reproductive age range.
- Eligible participants will be provided with a take-home lasagna meal.
- Participants will be given instructions and supplies for collection, storage and transportation of stool for the next visit.
- Participants will be provided with instructions for a low fiber, high fat diet which should be consumed for 2 days before stool collection and during the 2 days of stool collection. Instructions will also come with materials to allow participants to record diet intake during these 4 days.
- Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study
Day 1: this may be the same as Visit 1 or it may be a different day. It will depend upon the day that participants can make it back to the clinic for the Day 5 visit.
Day 2-4 (at home):
- Participants record stool symptoms and patterns in a diary daily starting from Day 2 to Day 5.
- During this time, participants will be instructed to consume a low fiber diet, avoid alcohol, and start a 4-day 100 g fat diet.
- On the evening before Day 5, a standardized, completely digestible, and non-fermentable meal (lasagna) will be consumed which will be provided to you on Day 1.
- Participants will collect stool at home on Day 4 and 5 and store as per instructions provided on Visit 1. They will
Day 5 (Visit 2):
- Participants return to the clinic on Day 5 after an overnight fast.
- You will receive a standard breakfast and lasanga meal with 10 g inulin (Orafti®) powder and 200 mL of water.
- Take-home meals will be provided (white bread sandwich with ham or cheese) to be consumed at 4 and 8 hours after breakfast.
Day 6 (Visit 3):
- Participants will return to the clinic in order to return stool collections and the daily diaries.
- Participants may also submit diaries by fax or email.
Day 30-90
- Optional dietary follow-up (Day 30-90): To further assess the utility of the 24 hour dietary recall, willing participants will be invited to participate in a an optional follow-up activity during which they will complete the Automated Self-Administered Dietary Assessment Tool with or without assistance of a trained interviewer. Interested volunteers will be contacted by phone and provided instructions on how to complete the tool online by the study team.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Inulin
- Keywords
- microbiome, microbiota, short chain fatty acids, prebiotic, bile acids
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Receives: Dietary Supplement: Inulin |
| Irritable Bowel Syndrome Patients with Diarrhea | Experimental | Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Receives: Dietary Supplement: Inulin |
| Irritable Bowel Syndrome Patients with Constipation | Experimental | Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Receives: Dietary Supplement: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Fecal Bile Acids
Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectometry
Measured: 48 hours
Total Fecal Short Chain Fatty Acids
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Measured: 48 hours
Individual Fecal Short Chain Fatty Acids - Acetate
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Measured: 48 hours
Individual Fecal Short Chain Fatty Acids - Propionate
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Measured: 48 hours
Individual Fecal Short Chain Fatty Acids - Butyrate
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Measured: 48 hours
Fecal Microbial Population
Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is.
Measured: 48 hours
Fecal Inulin
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
Measured: 48 hours
Secondary outcomes (4)
Percent Primary Fecal Bile Acids
Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectrometry. Percent primary bile acids is then calculated as primary bile acids divided by total bile acids multiplied by 100.
Measured: 48 hours
Stool Characteristics - Stool Frequency in 4 Days
Stool characteristics will be measured using a 4 day bowel diary. Stool frequency is the total number of bowel movements in 4 days summarized on the subject level.
Measured: 4 days
Stool Characteristics - Stool Form
Stool characteristics will be measured using a 4 day bowel diary. Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage,3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy,7=watery, summarized on the level of bowel movements.
Measured: 4 days
Stool Characteristics - Ease of Passage
Stool characteristics will be measured using a 4 day bowel diary. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start13 Aug 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Why it stopped: Study physician left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiping Xu, Indiana University
- Investigators
- Huiping XU, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983434
- Sponsor's protocol ID
- 1903209172
- Other IDs
- K23DK122015
- Status last verified
- Apr 2025
- First submitted
- 6 Jun 2019
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge
- ClinicalTrials.gov ID
- NCT03983434
- Acronym / sponsor ID
- 1903209172
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- microbiome, microbiota, short chain fatty acids, prebiotic, bile acids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study physician left the university
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.
Detailed description
The Study involves 3 visits and will in include 3 types of subjects - those who have irritable bowel syndrome (IBS) with constipation (IBS-C), IBS with diarrhea (IBS-D) and those who have no IBS symptoms or diagnosis.
Visit 1
- Volunteers will read and sign this informed consent after all questions about the study have been answered
- This is a screening visit and we may determine that volunteers ineligible to continue to participate in the study.
- Volunteers will have a medical history taken including demographics, history of symptoms and illness
- Volunteers will be asked about all medications
- A physical exam will be performed by the physician.
- Vital signs will be measured.
- Urine Pregnancy test may be done for woman in the reproductive age range.
- Eligible participants will be provided with a take-home lasagna meal.
- Participants will be given instructions and supplies for collection, storage and transportation of stool for the next visit.
- Participants will be provided with instructions for a low fiber, high fat diet which should be consumed for 2 days before stool collection and during the 2 days of stool collection. Instructions will also come with materials to allow participants to record diet intake during these 4 days.
- Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study
Day 1: this may be the same as Visit 1 or it may be a different day. It will depend upon the day that participants can make it back to the clinic for the Day 5 visit.
Day 2-4 (at home):
- Participants record stool symptoms and patterns in a diary daily starting from Day 2 to Day 5.
- During this time, participants will be instructed to consume a low fiber diet, avoid alcohol, and start a 4-day 100 g fat diet.
- On the evening before Day 5, a standardized, completely digestible, and non-fermentable meal (lasagna) will be consumed which will be provided to you on Day 1.
- Participants will collect stool at home on Day 4 and 5 and store as per instructions provided on Visit 1. They will
Day 5 (Visit 2):
- Participants return to the clinic on Day 5 after an overnight fast.
- You will receive a standard breakfast and lasanga meal with 10 g inulin (Orafti®) powder and 200 mL of water.
- Take-home meals will be provided (white bread sandwich with ham or cheese) to be consumed at 4 and 8 hours after breakfast.
Day 6 (Visit 3):
- Participants will return to the clinic in order to return stool collections and the daily diaries.
- Participants may also submit diaries by fax or email.
Day 30-90
- Optional dietary follow-up (Day 30-90): To further assess the utility of the 24 hour dietary recall, willing participants will be invited to participate in a an optional follow-up activity during which they will complete the Automated Self-Administered Dietary Assessment Tool with or without assistance of a trained interviewer. Interested volunteers will be contacted by phone and provided instructions on how to complete the tool online by the study team.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Dietary Supplement: InulinAdults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. |
| Irritable Bowel Syndrome Patients with Diarrhea | Experimental | Dietary Supplement: InulinPatients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS |
| Irritable Bowel Syndrome Patients with Constipation | Experimental | Dietary Supplement: InulinPatients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
- Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.
Key exclusion criteria (7 listed)
- Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT > 2.0x the upper limit of normal
- Prior radiation therapy of the abdomen or abdominal surgeries except for C-section, tubal ligation, vaginal hysterectomy and appendectomy or cholecystectomy, > 6 months prior to study initiation.
- Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed.
- Any females who are pregnant or trying to become pregnant or breast-feeding
- Antibiotic usage within 3 months prior to study participation
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 |
|---|---|---|
| InulinInulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. | Dietary supplement | Healthy volunteers, Irritable Bowel Syndrome Patients with Constipation, Irritable Bowel Syndrome Patients with Diarrhea |
Primary outcome
Total Fecal Bile Acids
Time frame: 48 hours
Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectometry
Total Fecal Short Chain Fatty Acids
Time frame: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Individual Fecal Short Chain Fatty Acids - Acetate
Time frame: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Individual Fecal Short Chain Fatty Acids - Propionate
Time frame: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Individual Fecal Short Chain Fatty Acids - Butyrate
Time frame: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Fecal Microbial Population
Time frame: 48 hours
Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is.
Fecal Inulin
Time frame: 48 hours
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
4 secondary outcomes
Percent Primary Fecal Bile Acids
Time frame: 48 hours
Stool Characteristics - Stool Frequency in 4 Days
Time frame: 4 days
Stool Characteristics - Stool Form
Time frame: 4 days
Stool Characteristics - Ease of Passage
Time frame: 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Huiping XU principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin in people with IBS - Irritable Bowel Syndrome, run by Indiana University 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 2 inclusion and 7 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 30 Apr 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Fecal Bile Acids (time frame: 48 hours). The study lists 7 primary outcomes in all. 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 30 Apr 2025.