IBS - Irritable Bowel SyndromeNCT04898257
Effect of Lactibiane Tolerance® to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)Patients
A study testing Multistrain probiotic in people with IBS - Irritable Bowel Syndrome, run by Larena SAS at 1 site in Italy.
Trial summary
This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients. 30 consecutive patients with IBS-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Multistrain probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2018to 25 Nov 2020
- Phase
- Interventional
- 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
- Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study at baseline visit:
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
- Male and/or female subjects between the ages of ≥18 and ≤75 years at the time of informed consent.
- Diagnosis of IBS following Rome IV criteria (Mearin et al., Gastroenterology 2016)*: Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
- related with defecation
Show all 11Show fewer
- associated with a change in frequency of stool
- onset associated with a change in form (appearance) of stool * Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
- Diagnosis of IBS with predominant diarrhea (IBS-D), following Rome IV criteria (Mearin et al., Gastroenterology 2016): more than one fourth (25%) of bowel movements with Bristol stool form types 6 or 7 and less than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2 or Patient reports that abnormal bowel movements are usually diarrhea (like type 6 or 7 in the picture of Bristol Stool Form Scale)
- Evidence of a colonoscopy performed 5 years within the enrolment showing no evidence of organic disease
- Evidence of increased intestinal permeability at 51Cr-EDTA or 99mTc-DTPA assessment performed during screening phase.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Subjects with suspect or evidence of organic disease, including but not limited to coeliac disease, inflammatory bowel disease, gastrointestinal neoplasia, unexplained anemia
- Subjects with a history of colonic or small bowel resection.
- Subjects with lactose intolerance
- Use of probiotics or antibiotics or investigational agents within 30 days before baseline
- Repeated use of anti-inflammatory drugs, including the non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen within 7 days from the enrolment (except for prophylactic use of a stable dose of aspirin up to 325 mg / day for cardiac disease) and use of any product or ingredient that can have an effect on the intestinal permeability.
Show all 9Show fewer
- Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active infection/infectious illness) that, in the investigator's judgement will substantially increase the risk to the subject if he or she participates in the study.
- Normal intestinal permeability at 51Cr-EDTA or 99mTc-DTPA assessment performed during screening
- Women during pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lactibiane Tolerance®, a Multistrain Probiotic, to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D) Patients: an Open-label, Single-center, Proof-of-concept, Pilot Study
This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients.
30 consecutive patients with IBS-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day (30 minutes before breakfast and 30 minutes before dinner) for 30 days treatment. At the end of treatment, patients will repeat intestinal permeability assessment by 51Cr-EDTA or 99mTc-DTPA.
Read the detailed description
Gut microbiota has many beneficial effects on the GI tract: barrier, immunomodulatory, metabolic, trophic among others. Microbiota unbalance or dysbiosis has been associated to digestive and extradigestive diseases.
Irritable bowel syndrome (IBS) is a common chronic disorder that affects the small and large intestine which causes cramping, abdominal pain, bloating, gas, diarrhea and/or constipation. Only a small number of people with IBS have severe signs and symptoms. Some people can control their symptoms by managing diet, lifestyle and stress. Others will need medication and counseling.
Intestinal permeability is the phenomenon of the gut wall in the gastrointestinal tract exhibiting permeability. It is a normal function of the intestine to exhibit some permeability, to allow nutrients to pass through the gut, while also maintaining a barrier function to keep potentially harmful substances (such as antigens) from leaving the intestine and migrating to the body more widely. In a healthy human intestine, small particles (< 4 Å in radius) can migrate through tight junction claudin pore pathways and particles up to 10-15 Å (3.5 kDa) can transit through the paracellular space uptake route. One way in which intestinal permeability is modulated is via CXCR3 receptors in the gut wall, which respond to zonulin. Gliadin (a glycoprotein present in wheat) activates zonulin signaling irrespective of the genetic expression of autoimmunity, leading to increased intestinal permeability to macromolecules. Bacterial pathogens such as cholera, select enteric viruses, and parasites modulate intestinal tight junction structure and function, and these effects may contribute to the development of chronic intestinal disorders. Excessive intestinal permeability is a factor in stress, infections and in some several autoimmune conditions such as Crohn's disease, celiac disease, type 1 diabetes, rheumatoid arthritis, spondyloarthropathies, inflammatory bowel disease and irritable bowel syndrome, but it is not clear if increased intestinal permeability is a cause or a consequence of these conditions.
According to its ability to modulate gut associated immune system, to compete with other GI bacteria and to increase enterocyte regeneration, probiotic therapy could be proposed to overcome an increased intestinal permeability. In particular, preliminary data suggested that the probiotic multistrains Lactibiane Tolerance® could be effective in Leaky gut treatment.
In fact, Nébot-Vivinus et al. demonstrated that Lactibiane Tolerance® could prevent epithelial barrier disruption induced by lipopolysaccharide, stress or colonic soluble factors from IBS patients and prevent visceral hypersensitivity in experimental models of epithelial barrier function.
Furthermore, Drouault-Holowacz et al. demonstrated that Lactibiane Tolerance® has anti-inflammatory properties in vitro by stimulating IL-10 production and in vivo by conferring a significant protective effect in the 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced colitis -induced colitis model (more than 50% decrease of colitis symptoms, P<0.01).This pilot study has been designed to evaluate the effect of multistrains probiotic Lactibiane Tolerance® in a consecutive subset of IBS-D patients with increased Intestinal permeability.
Subject participation in this study will be for approximately 45 days which includes up to a 2-week screening period and a 30-day treatment period.
All subjects will participate to the following visits: screening, enrolment, day 15 and day 30.
30 IBS-D patients Objectives Primary objective To demonstrate the effect of the multistrain probiotic Lactibiane Tolerance® in normalizing leaky gut in IBS-D patients Secondary objectives
- To characterize the effect of Lactibiane Tolerance® in improving symptoms of IBS
- To characterize the effect of Lactibiane Tolerance® on serum levels of zonulin
- To characterize the effect of Lactibiane Tolerance® on stool consistency
- To characterize the effect of Lactibiane Tolerance® on quality of life
- To evaluate the safety and tolerability of Lactibiane Tolerance®. Primary endpoint Proportion of subjects with normal intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA after 30 days of treatment.
Secondary endpoints
- Mean variation of scores of items evaluated by VAS-IBS questionnaire after treatment compared to baseline
- Percentage of patients answering "yes" to the self-evaluation question: "Do you feel that your IBS symptoms have been satisfactory alleviated by this treatment?"
- Mean concentration of serum zonulin before and after treatment
- Mean score on Bristol Stool Scale before and after treatment and proportions of patients with 6 and 7 on Bristol Stool scale before and after treatment
- Mean score of IBSQoL questionnaire before and after treatment
- Safety and tolerability evaluated by the frequency of AEs, SAEs and AEs leading to discontinuation of study treatment.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Multistrain probiotic
- 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.
Multistrain probioticDietary supplement
Also called Lactibiane Tolerance®
After completion of screening phase, during baseline visit, eligible patients will be assigned to Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day on an empty stomach (30 minutes before breakfast and 30 minutes before dinner).
| Study group | Role | What they receive |
|---|---|---|
| Lactibiane Tolerance® | Other | 30 consecutive patients with IBS-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day (30 minutes before breakfast and 30 minutes before dinner) for 30 days treatment. At the end of treatment, patients will repeat intestinal permeability assessment by 51Cr-EDTA or 99mTc-DTPA. Receives: Dietary Supplement: Multistrain probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with normal intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA
To demonstrate the effect of the multistrain probiotic Lactibiane Tolerance® in normalizing leaky gut in IBS-D patients
Measured: 30 days
Secondary outcomes (7)
Mean variation of scores of items evaluated by VAS-IBS questionnaire after treatment compared to baseline
To characterize the effect of Lactibiane Tolerance® in improving symptoms of IBS.
Measured: 30 days
Percentage of patients answering "yes" to the self-evaluation question: "Do you feel that your IBS symptoms have been satisfactory alleviated by this treatment?"
To characterize the effect of Lactibiane Tolerance® in improving symptoms of IBS.
Measured: 30 days
Mean concentration of serum zonulin before and after treatment
To characterize the effect of Lactibiane Tolerance® on serum levels of zonulin
Measured: 30 days
Mean score on Bristol Stool Scale before and after treatment
To characterize the effect of Lactibiane Tolerance® on stool consistency.
Measured: 30 days
Proportions of patients with 6 and 7 on Bristol Stool scale before and after treatment
To characterize the effect of Lactibiane Tolerance® on stool consistency.
Measured: 30 days
Mean score of IBSQoL questionnaire before and after treatment
To characterize the effect of Lactibiane Tolerance® on quality of life.
Measured: 30 days
Safety and tolerability evaluated by the frequency of AEs, SAEs and AEs leading to discontinuation of study treatment.
To evaluate the safety and tolerability of Lactibiane Tolerance®.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start17 May 2018
- Primary completion8 Oct 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larena SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samira Aït Abdellah, Study chair, Laboratoire PILEJE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898257
- Sponsor's protocol ID
- PILEJE-Lactibiane Tolerance
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactibiane Tolerance®, a Multistrain Probiotic, to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D) Patients: an Open-label, Single-center, Proof-of-concept, Pilot Study
- ClinicalTrials.gov ID
- NCT04898257
- Acronym / sponsor ID
- PILEJE-Lactibiane Tolerance
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Larena SASIndustry (pharma, biotech, devices)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 24 May 2021 (actual)
- 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.
This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients.
30 consecutive patients with IBS-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day (30 minutes before breakfast and 30 minutes before dinner) for 30 days treatment. At the end of treatment, patients will repeat intestinal permeability assessment by 51Cr-EDTA or 99mTc-DTPA.
Detailed description
Gut microbiota has many beneficial effects on the GI tract: barrier, immunomodulatory, metabolic, trophic among others. Microbiota unbalance or dysbiosis has been associated to digestive and extradigestive diseases.
Irritable bowel syndrome (IBS) is a common chronic disorder that affects the small and large intestine which causes cramping, abdominal pain, bloating, gas, diarrhea and/or constipation. Only a small number of people with IBS have severe signs and symptoms. Some people can control their symptoms by managing diet, lifestyle and stress. Others will need medication and counseling.
Intestinal permeability is the phenomenon of the gut wall in the gastrointestinal tract exhibiting permeability. It is a normal function of the intestine to exhibit some permeability, to allow nutrients to pass through the gut, while also maintaining a barrier function to keep potentially harmful substances (such as antigens) from leaving the intestine and migrating to the body more widely. In a healthy human intestine, small particles (< 4 Å in radius) can migrate through tight junction claudin pore pathways and particles up to 10-15 Å (3.5 kDa) can transit through the paracellular space uptake route. One way in which intestinal permeability is modulated is via CXCR3 receptors in the gut wall, which respond to zonulin. Gliadin (a glycoprotein present in wheat) activates zonulin signaling irrespective of the genetic expression of autoimmunity, leading to increased intestinal permeability to macromolecules. Bacterial pathogens such as cholera, select enteric viruses, and parasites modulate intestinal tight junction structure and function, and these effects may contribute to the development of chronic intestinal disorders. Excessive intestinal permeability is a factor in stress, infections and in some several autoimmune conditions such as Crohn's disease, celiac disease, type 1 diabetes, rheumatoid arthritis, spondyloarthropathies, inflammatory bowel disease and irritable bowel syndrome, but it is not clear if increased intestinal permeability is a cause or a consequence of these conditions.
According to its ability to modulate gut associated immune system, to compete with other GI bacteria and to increase enterocyte regeneration, probiotic therapy could be proposed to overcome an increased intestinal permeability. In particular, preliminary data suggested that the probiotic multistrains Lactibiane Tolerance® could be effective in Leaky gut treatment.
In fact, Nébot-Vivinus et al. demonstrated that Lactibiane Tolerance® could prevent epithelial barrier disruption induced by lipopolysaccharide, stress or colonic soluble factors from IBS patients and prevent visceral hypersensitivity in experimental models of epithelial barrier function.
Furthermore, Drouault-Holowacz et al. demonstrated that Lactibiane Tolerance® has anti-inflammatory properties in vitro by stimulating IL-10 production and in vivo by conferring a significant protective effect in the 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced colitis -induced colitis model (more than 50% decrease of colitis symptoms, P<0.01).This pilot study has been designed to evaluate the effect of multistrains probiotic Lactibiane Tolerance® in a consecutive subset of IBS-D patients with increased Intestinal permeability.
Subject participation in this study will be for approximately 45 days which includes up to a 2-week screening period and a 30-day treatment period.
All subjects will participate to the following visits: screening, enrolment, day 15 and day 30.
30 IBS-D patients Objectives Primary objective To demonstrate the effect of the multistrain probiotic Lactibiane Tolerance® in normalizing leaky gut in IBS-D patients Secondary objectives
- To characterize the effect of Lactibiane Tolerance® in improving symptoms of IBS
- To characterize the effect of Lactibiane Tolerance® on serum levels of zonulin
- To characterize the effect of Lactibiane Tolerance® on stool consistency
- To characterize the effect of Lactibiane Tolerance® on quality of life
- To evaluate the safety and tolerability of Lactibiane Tolerance®. Primary endpoint Proportion of subjects with normal intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA after 30 days of treatment.
Secondary endpoints
- Mean variation of scores of items evaluated by VAS-IBS questionnaire after treatment compared to baseline
- Percentage of patients answering "yes" to the self-evaluation question: "Do you feel that your IBS symptoms have been satisfactory alleviated by this treatment?"
- Mean concentration of serum zonulin before and after treatment
- Mean score on Bristol Stool Scale before and after treatment and proportions of patients with 6 and 7 on Bristol Stool scale before and after treatment
- Mean score of IBSQoL questionnaire before and after treatment
- Safety and tolerability evaluated by the frequency of AEs, SAEs and AEs leading to discontinuation of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients.
| Arm | Type | Receives |
|---|---|---|
| Lactibiane Tolerance® | Other | Dietary Supplement: Multistrain probiotic30 consecutive patients with IBS-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day (30 minutes before breakfast and 30 minutes before dinner) for 30 days treatment. At the end of treatment, patients will repeat intestinal permeability assessment by 51Cr-EDTA or 99mTc-DTPA. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study at baseline visit:
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
- Male and/or female subjects between the ages of ≥18 and ≤75 years at the time of informed consent.
- Diagnosis of IBS following Rome IV criteria (Mearin et al., Gastroenterology 2016)*: Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
Key exclusion criteria (9 listed)
- Subjects with suspect or evidence of organic disease, including but not limited to coeliac disease, inflammatory bowel disease, gastrointestinal neoplasia, unexplained anemia
- Subjects with a history of colonic or small bowel resection.
- Subjects with lactose intolerance
- Use of probiotics or antibiotics or investigational agents within 30 days before baseline
- Repeated use of anti-inflammatory drugs, including the non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen within 7 days from the enrolment (except for prophylactic use of a stable dose of aspirin up to 325 mg / day for cardiac disease) and use of any product or ingredient that can have an effect on the intestinal permeability.
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 |
|---|---|---|
| Multistrain probioticAlso: Lactibiane Tolerance®After completion of screening phase, during baseline visit, eligible patients will be assigned to Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day on an empty stomach (30 minutes before breakfast and 30 minutes before dinner). | Dietary supplement | Lactibiane Tolerance® |
Primary outcome
Proportion of subjects with normal intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA
Time frame: 30 days
To demonstrate the effect of the multistrain probiotic Lactibiane Tolerance® in normalizing leaky gut in IBS-D patients
7 secondary outcomes
Mean variation of scores of items evaluated by VAS-IBS questionnaire after treatment compared to baseline
Time frame: 30 days
Percentage of patients answering "yes" to the self-evaluation question: "Do you feel that your IBS symptoms have been satisfactory alleviated by this treatment?"
Time frame: 30 days
Mean concentration of serum zonulin before and after treatment
Time frame: 30 days
Mean score on Bristol Stool Scale before and after treatment
Time frame: 30 days
Proportions of patients with 6 and 7 on Bristol Stool scale before and after treatment
Time frame: 30 days
Mean score of IBSQoL questionnaire before and after treatment
Time frame: 30 days
Safety and tolerability evaluated by the frequency of AEs, SAEs and AEs leading to discontinuation of study treatment.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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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.
Samira Aït Abdellah study chair
Laboratoire PILEJE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multistrain probiotic in people with IBS - Irritable Bowel Syndrome, run by Larena SAS at 1 site in Italy.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 24 May 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with normal intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA (time frame: 30 days). 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 24 May 2021.