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

NCT03318614 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-10-24

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Probiotics M-63

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

OTHER

Control group

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

Sponsors & Collaborators

  • Morinaga Milk Industry Co., LTD

    collaborator INDUSTRY

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Yeong Yeh Lee, MD, PhD · Universiti Sains Malaysia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318614 on ClinicalTrials.gov