L. Reuteri DSM 17938 and L. Reuteri ATCC PTA 6475 in Moderate to Severe Irritable Bowel in Adults

NCT04037826 | Completed

• 1 other identifier: CSUB 0137
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 2

Brief Summary

Randomized, double blind, controlled clinical trial, to evaluate safety and efficacy of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475 as adjuvant to reduce the severity of symptoms in adults with moderate to severe irritable bowel syndrome (IBS). Primary outcome: Global clinical Improve assessed by the GSRS-IBS score. Adults 18-65 years, any gender, with ROME IV criteria for moderate to severe IBS and body max index \<36 will be included. Prescreening will be run for 2 weeks, the intervention period will be 2/days for 14t weeks, follow by a 2 weeks period of observation with no intervention. Secondary outcomes include: a) Improvements in the stool patterns evaluated through Bristol Stool Form (BSF); b) Improvement of the quality of life (QoL) measured by Latin-American IBS-QoL questionnaire; c) Improvement of the depression and anxiety severity evaluated by the Goldberg Depression and Anxiety Scale; d) Frequency of rescue medication use and e) Frequency of Adverse Events (AEs)

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome, adults, L. reuteri

Outcome Measures

Primary Outcomes (1)

• Global clinical improvement

  Global Clinical Improvement assessed by the GSRS-IBS score (Spanish/LA version). GSRS-IBS is a multidimensional score aimed to evaluate the severity of gastrointestinal IBS symptoms after and during treatment. It contains 13 items related to severity of abdominal pains, passing stools, abdominal tenderness, passing gas, constipation, diarrhea, etc. which had been validates in different languages.

  16 weeks

Secondary Outcomes (5)

• Improve on Stool Consistency

  16 weeks

• Improve on Quality of Life

  16 weeks

• Improve on Depression

  16 weeks

• Use of rescue medication

  16 weeks

• Adverse events

  16 weeks

Study Arms (2)

L. reuteri Gastrus

EXPERIMENTAL

L. reuteri Gastrus (L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475)

Dietary Supplement: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

Placebo

PLACEBO COMPARATOR

Placebo chewable tablets

Dietary Supplement: Placebo

Interventions

L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475 DIETARY_SUPPLEMENT

L. reuteri Gastrus (L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475) at dose of 2x108 Colony Forming Units (CFU) per tablet. One chewable tablet is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day.

L. reuteri Gastrus

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Any gender
• ROME IV diagnostic criteria for IBS
• A baseline GSRS-IBS score (Spanish/LA version) moderate to severe IBS
• Body Mass Index (BMI) 25 to 35
• Patient capable of conforming to the protocol
• Signed Informed consent

You may not qualify if:

• Patients with relevant systemic, organic or metabolic diseases
• Patients with abnormal laboratory values that could be relevant to the outcome of study treatment
• Previous recent major abdominal surgery
• Consumption of antibiotics, Proton-Pump Inhibitors, H2-antagonists or dietary supplements containing Lactobacillus reuteri within 2 weeks prior to base-line
• Pregnancy

Sponsors & Collaborators

• Innovacion y Desarrollo de Estrategias en Salud: lead
• BioGaia AB: collaborator

Study Sites (2)

Instituto de Nutricion y Tecnologia de los Alimentos

Santiago, Chile

Location

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, 14080, Mexico

Location

Related Publications (5)

• McFarland LV, Dublin S. Meta-analysis of probiotics for the treatment of irritable bowel syndrome. World J Gastroenterol. 2008 May 7;14(17):2650-61. doi: 10.3748/wjg.14.2650.

  PMID: 18461650 RESULT

• Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx-Orenstein AE, Brandt LJ, Quigley EM. The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325-32. doi: 10.1136/gut.2008.167270. Epub 2008 Dec 17.

  PMID: 19091823 RESULT

• Tiequn B, Guanqun C, Shuo Z. Therapeutic effects of Lactobacillus in treating irritable bowel syndrome: a meta-analysis. Intern Med. 2015;54(3):243-9. doi: 10.2169/internalmedicine.54.2710.

  PMID: 25748731 RESULT

• Didari T, Mozaffari S, Nikfar S, Abdollahi M. Effectiveness of probiotics in irritable bowel syndrome: Updated systematic review with meta-analysis. World J Gastroenterol. 2015 Mar 14;21(10):3072-84. doi: 10.3748/wjg.v21.i10.3072.

  PMID: 25780308 RESULT

• Zhang Y, Li L, Guo C, Mu D, Feng B, Zuo X, Li Y. Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria: a meta-analysis. BMC Gastroenterol. 2016 Jun 13;16(1):62. doi: 10.1186/s12876-016-0470-z.

  PMID: 27296254 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed by Sponsor. Products will be send to research centers in blind bottles. Tablets for active and placebo have the same color and taste. Labelling will be performed in research centers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research for Mother-Child

Model Details: Randomized, double blind, controlled clinical trial, with two branches. Randomization will be centralized performed by sponsor. L. reuteri Gastrus at dose of 2x108 Colony Forming Units (CFU) or placebo will be adminsitrated twice per day

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: July 30, 2019
• Study Start: July 12, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2022
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

ME (1); CL (1)