Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster

NCT03318614 | Completed Phase 2 DMC

• 1 other identifier: USM/JEPeM/15040133
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

A 3-month study was conducted in flood victims from affected villages in the Tumpat district, Kelantan. Participants were given either probiotic, Bifidobacterium infantis M63 (M-63 group) or no probiotics (control group) for three months. At baseline and 3-month, participants were assessed for thewater, sanitation and hygiene (WaSH) practices, abdominal symptoms, breath testing for hydrogen and methane to detect the presence of SIBO and also fecal samples for gut microbiota profiling.

Conditions

Irritable Bowel Syndrome; Abdominal Pain; Small Intestinal Bacterial Overgrowth

Keywords

Gut Microbiota; Probiotics; Abdominal Pain; Small Intestinal Bacterial Overgrowth; Mental

Outcome Measures

Primary Outcomes (1)

• IBS Symptom Severity Scale (IBS-SSS) scores

  IBS-SSS contains five questions that determine severity of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits and interference with quality of life (QOL) on a 100-point visual analogue scale. Since each question contributes to the score equally, therefore 500 is the maximum score, and higher the score, the severity is worse. For those participants with scores below 175, they have mild IBS, and in general, if scores are below 75, they are considered in remission. No units of measure are used.

  Three months

Secondary Outcomes (4)

• 36-Item Short Form Survey (SF-36) scores

  Three months

• Hospital Anxiety and Depression Scale (HADS) scores

  Three months

• Breath-testing for small intestinal bacterial overgrowth (SIBO)

  Three months

• Changes in gut microbiota at the phylum level

  Three months

Study Arms (2)

Probiotics M-63 group

EXPERIMENTAL

Participants assigned to the M-63 group were given a sachet of B. infantis M63 (Morinaga Milk Industry Co., Ltd., Japan) to consume daily in addition to advice of good hygiene and sanitation practices.

Dietary Supplement: Probiotics M-63

Control group

PLACEBO COMPARATOR

No probiotic intervention was given to the control group over three months other than advice of good hygiene and sanitation practices.

Other: Control group

Interventions

Probiotics M-63 DIETARY_SUPPLEMENT

B. infantis M63 (2.5 x 109 cfu/g per sachet) was given to Probiotics M-63 group for three months.

Probiotics M-63 group

Control group OTHER

No probiotic intervention was given to the control group for three months.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years; flood victims who fulfilled the Rome III criteria for IBS developed after flood, able to perform breath-testing, able to provide stool specimens, and able to complete three months of prospective intervention.

You may not qualify if:

• Adults who took antibiotics or probiotics three months prior to and after flood had taken place; previous abdominal surgery and presence of significant medical and psychiatric co-morbidities.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Morinaga Milk Industry Co., LTD: collaborator

Related Publications (1)

• Ma ZF, Yusof N, Hamid N, Lawenko RM, Mohammad WMZW, Liong MT, Sugahara H, Odamaki T, Xiao J, Lee YY. Bifidobacterium infantis M-63 improves mental health in victims with irritable bowel syndrome developed after a major flood disaster. Benef Microbes. 2019 Mar 13;10(2):111-120. doi: 10.3920/BM2018.0008. Epub 2018 Dec 10.

  PMID: 30525951 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yeong Yeh Lee, MD, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Model Details: Participants assigned to the M-63 group were given a sachet of B. infantis M63 (2.5 x 109 cfu/g per sachet) (Morinaga Milk Industry Co. Ltd., Japan) to consume daily for three months in addition to advice of good hygiene and sanitation practices. No drug intervention was given to the control group over three months other than advice of good hygiene and sanitation practices.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 24, 2017
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share