Diarrhea-Predominant Irritable Bowel SyndromePhase 2AT005291NCT01414244
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
A Phase 2 study testing Glutamine in people with Diarrhea-Predominant Irritable Bowel Syndrome, run by Tulane University at 1 site in United States.
Trial summary
New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed… Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Diarrhea-Predominant Irritable Bowel Syndrome
- What is being tested?
- Glutamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 30 Dec 2015
- Phase
- Phase 2
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS)
- increased intestinal permeability on Lactulose/Mannitol permeability test
- able and willing to cooperate with the study
- *absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration
Who cannot join
- current participation in another research protocol or unable to give informed consent
- women with a positive urine pregnancy test or breastfeeding
- history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue
- + hydrogen breath test for bacterial overgrowth
- + antiendomysial antibody titer
- use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study
Show all 9Show fewer
- known allergy to glutamine
- abdominal surgery except for removal of gallbladder, uterus, or appendix
- Abnormal blood urea nitrogen(BUN) and/or creatinine
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University School of Medicine
New Orleans, Louisiana, 70112
About this study
Official title: Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.
Read the detailed description
In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).
- Being tested
- Glutamine
- Keywords
- Irritable Bowel Syndrome, Glutamine, Intestinal Permeability
- 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.
GlutamineDrug
Also called L-Glutamine
Drug
| Study group | Role | What they receive |
|---|---|---|
| Glutamine supplementation | Active comparator | Glutamine Receives: Drug: Glutamine |
| Placebo | Placebo comparator | Whey protein powder Receives: Drug: Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Irritable Bowel Symptom Severity Scale
The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.
Measured: baseline and 8 weeks following therapy
Secondary outcomes (3)
Intestinal Permeability
The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol.
Measured: baseline and 8 weeks following therapy
Stool Frequency
Baseline and 8 week at the conclusion of therapy
Measured: Baseline and 8 weeks following therapy
Stool Consistency
Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome.
Measured: Baseline and 8 weeks following therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startNov 2010
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea-Predominant 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Verne, Tulane University
- Investigators
- QiQi Zhou, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414244
- Sponsor's protocol ID
- 11-271
- Acronym
- AT005291
- Status last verified
- Aug 2017
- First submitted
- 29 Jul 2011
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Some data will be available through publications, however further plans to make all IPD available is unknown.
Publications
Zhou Q, Verne ML, Fields JZ, Lefante JJ, Basra S, Salameh H, Verne GN. Randomised placebo-controlled trial of dietary glutamine supplements for postinfectious irritable bowel syndrome. Gut. 2019 Jun;68(6):996-1002. doi: 10.1136/gutjnl-2017-315136. Epub 2018 Aug 14.
PubMed 30108163
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01414244
- Acronym / sponsor ID
- AT005291 / 11-271
- Keywords
- Irritable Bowel Syndrome, Glutamine, Intestinal Permeability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Posted 9 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.
Detailed description
In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine supplementation | Active comparator | Drug: GlutamineGlutamine |
| Placebo | Placebo comparator | Drug: GlutamineWhey protein powder |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS)
- increased intestinal permeability on Lactulose/Mannitol permeability test
- able and willing to cooperate with the study
- *absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration
Key exclusion criteria (9 listed)
- current participation in another research protocol or unable to give informed consent
- women with a positive urine pregnancy test or breastfeeding
- history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue
- + hydrogen breath test for bacterial overgrowth
- + antiendomysial antibody titer
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 |
|---|---|---|
| GlutamineAlso: L-GlutamineDrug | Drug | Glutamine supplementation, Placebo |
Primary outcome
Change in the Irritable Bowel Symptom Severity Scale
Time frame: baseline and 8 weeks following therapy
The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.
3 secondary outcomes
Intestinal Permeability
Time frame: baseline and 8 weeks following therapy
Stool Frequency
Time frame: Baseline and 8 weeks following therapy
Stool Consistency
Time frame: Baseline and 8 weeks following therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30108163Zhou Q, Verne ML, Fields JZ, Lefante JJ, Basra S, Salameh H, Verne GN. Randomised placebo-controlled trial of dietary glutamine supplements for postinfectious irritable bowel syndrome. Gut. 2019 Jun;68(6):996-1002. doi: 10.1136/gutjnl-2017-315136. Epub 2018 Aug 14.
- Individual participant dataSharing planned: Undecided. Some data will be available through publications, however further plans to make all IPD available is unknown.
Related trials for Diarrhea-Predominant Irritable Bowel Syndrome
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
Not yet recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea
Not yet recruitingPhase 3
Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
Diarrhea-predominant Irritable Bowel Syndrome
Not yet recruitingPhase 3
Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)
IBS, Diarrhea Predominant
Recruiting
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
Diarrhea-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
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.
QiQi Zhou principal investigator
Tulane University School of Medicine
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 Glutamine in people with Diarrhea-Predominant Irritable Bowel Syndrome, run by Tulane 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 4 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 9 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2017). 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?
Change in the Irritable Bowel Symptom Severity Scale (time frame: baseline and 8 weeks following therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414244, which also lists 1 linked publication.
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 9 Aug 2017.