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

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ClinicalTrials.gov Identifier: NCT03318614
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
Morinaga Milk Industry Co. Ltd., Japan
Information provided by (Responsible Party):
Yeong Yeh Lee, University of Science Malaysia

Tracking Information
First Submitted Date  ICMJE October 12, 2017
First Posted Date  ICMJE October 24, 2017
Last Update Posted Date October 24, 2017
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
IBS Symptom Severity Scale (IBS-SSS) scores [ Time Frame: Three months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
  • 36-Item Short Form Survey (SF-36) scores [ Time Frame: Three months ]
    SF-36 measures four physical components (i.e. physical functioning, role limitations in physical health, bodily pain and general health perception) and four mental components (i.e. social functioning, role limitations due to emotional problems, vitality or energy and mental well-being). Total physical component and total mental component were calculated as the sum of all items in the physical and mental components, respectively. Participants with a higher score in each domain of SF-36 have a better quality of life (QOL) in that domain. No units of measure are used.
  • Hospital Anxiety and Depression Scale (HADS) scores [ Time Frame: Three months ]
    The Malay-translated version of 14-item HADS contains four-point Likert responses Participants with higher scores had worse anxiety and depression. No units of measure are used.
  • Breath-testing for small intestinal bacterial overgrowth (SIBO) [ Time Frame: Three months ]
    Participants were asked to exhale end-expiratory breath samples into a collection bag at baseline. Then they were asked to drink 75 g of glucose in cold water. At intervals of 15 mins for the next 2 hours, breath samples were collected and symptoms recorded. Forty mL of exhaled breath were syringed into the machine (Quintron, Milwaukee, US), and levels of H2 and CH4 (in parts per million or ppm) were determined. For a positive test, the following criteria were applied: a rise in H2 value (≥ 20 ppm) or CH4 values (≥ 10 ppm) above fasting baseline value or a sustained rise in H2 or CH4 of 5 ppm over 3 consecutive breath samples. A rise in breath values as above and reproduction of symptoms were required to diagnose SIBO.
  • Changes in gut microbiota at the phylum level [ Time Frame: Three months ]
    Fresh fecal specimens were collected and gut microbial analysis was performed. Changes in gut microbiota at the phylum level were reported in terms of relative abundance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
Official Title  ICMJE Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Masking Description:
No masking
Primary Purpose: Treatment
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Abdominal Pain
  • Small Intestinal Bacterial Overgrowth
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: Probiotics M-63
  • Placebo Comparator: Control group
    No probiotic intervention was given to the control group over three months other than advice of good hygiene and sanitation practices.
    Intervention: Other: Control group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2017)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03318614
Other Study ID Numbers  ICMJE USM/JEPeM/15040133
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Responsible Party Yeong Yeh Lee, University of Science Malaysia
Study Sponsor  ICMJE University of Science Malaysia
Collaborators  ICMJE Morinaga Milk Industry Co. Ltd., Japan
Investigators  ICMJE
Principal Investigator: Yeong Yeh Lee, MD, PhD University of Science Malaysia
PRS Account University of Science Malaysia
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP