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

NCT ID: NCT03318614

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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There is an observed rise in cases of acute gastroenteritis and post-infectious irritable bowel syndrome (PI-IBS) during the peak flood period. One major reason is poor sanitation, water and hygiene practice by flood victims during the flood because of poor access to clean water. The mechanism how poor hygiene causes non-specific abdominal complaints is unknown. The investigators speculated that small intestinal overgrowth (SIBO) is the fundamental basis for the increase in reported cases of acute gastroenteritis and abdominal complaints among flood victims. The investigators further speculated that administration of antibiotics or probiotics could reduce the abdominal symptoms after three months.

Therefore, the intervention study was conducted for three months. Compliance of participants was checked by a diary given to participants in the M-63 group to document their daily intake of probiotics. This study will for the first time demonstrate the fundamental mechanism behind the poor WaSH practices and gastrointestinal disturbances after flood. Also this study would support a role for probiotic intervention to reduce abdominal complications when the next flood occurs.

Conditions

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Irritable Bowel Syndrome Abdominal Pain Small Intestinal Bacterial Overgrowth

Keywords

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Gut Microbiota Probiotics Abdominal Pain Small Intestinal Bacterial Overgrowth Mental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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Probiotics M-63 group

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.

Group Type EXPERIMENTAL

Probiotics M-63

Intervention Type DIETARY_SUPPLEMENT

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

Control group

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

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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Probiotics M-63

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

Intervention Type DIETARY_SUPPLEMENT

Control group

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Morinaga Milk Industry Co., LTD

INDUSTRY

Sponsor Role collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Yeong Yeh Lee

Professor Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yeong Yeh Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

References

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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.

Reference Type DERIVED
PMID: 30525951 (View on PubMed)

Other Identifiers

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USM/JEPeM/15040133

Identifier Type: -

Identifier Source: org_study_id