NCT01414244

Brief 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 diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 9, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

5.2 years

First QC Date

July 29, 2011

Results QC Date

April 10, 2017

Last Update Submit

August 7, 2017

Conditions

Diarrhea-Predominant Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeGlutamineIntestinal Permeability

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and 8 weeks following therapy

Secondary Outcomes (3)

  • Intestinal Permeability

    baseline and 8 weeks following therapy

  • Stool Frequency

    Baseline and 8 weeks following therapy

  • Stool Consistency

    Baseline and 8 weeks following therapy

Study Arms (2)

Glutamine supplementation

ACTIVE COMPARATOR

Glutamine

Drug: Glutamine

Placebo

PLACEBO COMPARATOR

Whey protein powder

Drug: Glutamine

Interventions

GlutamineDRUG

Drug

Also known as: L-Glutamine
Glutamine supplementationPlacebo

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • known allergy to glutamine
  • abdominal surgery except for removal of gallbladder, uterus, or appendix
  • Abnormal blood urea nitrogen(BUN) and/or creatinine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

  • 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.

    PMID: 30108163DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Results Point of Contact

Title
QiQi Zhou
Organization
Tulane University
qiqi06@gmail.com
988-7800

Study Officials

  • QiQi Zhou

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 11, 2011

Study Start

November 1, 2010

Primary Completion

December 30, 2015

Study Completion

December 30, 2015

Last Updated

August 9, 2017

Results First Posted

August 9, 2017

Record last verified: 2017-08

Locations

US(1)