Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
Primary Purpose
Irritable Bowel Syndrome, Abdominal Pain, Small Intestinal Bacterial Overgrowth
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Probiotics M-63
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Gut Microbiota, Probiotics, Abdominal Pain, Small Intestinal Bacterial Overgrowth, Mental
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotics M-63 group
Control group
Arm Description
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.
No probiotic intervention was given to the control group over three months other than advice of good hygiene and sanitation practices.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
36-Item Short Form Survey (SF-36) scores
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
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)
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
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.
Full Information
NCT ID
NCT03318614
First Posted
October 12, 2017
Last Updated
October 18, 2017
Sponsor
Universiti Sains Malaysia
Collaborators
Morinaga Milk Industry Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT03318614
Brief Title
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
Official Title
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
Collaborators
Morinaga Milk Industry Co., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Abdominal Pain, Small Intestinal Bacterial Overgrowth
Keywords
Gut Microbiota, Probiotics, Abdominal Pain, Small Intestinal Bacterial Overgrowth, Mental
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics M-63 group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
No probiotic intervention was given to the control group over three months other than advice of good hygiene and sanitation practices.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics M-63
Intervention Description
B. infantis M63 (2.5 x 109 cfu/g per sachet) was given to Probiotics M-63 group for three months.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No probiotic intervention was given to the control group for three months.
Primary Outcome Measure Information:
Title
IBS Symptom Severity Scale (IBS-SSS) scores
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
36-Item Short Form Survey (SF-36) scores
Description
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.
Time Frame
Three months
Title
Hospital Anxiety and Depression Scale (HADS) scores
Description
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.
Time Frame
Three months
Title
Breath-testing for small intestinal bacterial overgrowth (SIBO)
Description
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.
Time Frame
Three months
Title
Changes in gut microbiota at the phylum level
Description
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.
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeong Yeh Lee, MD, PhD
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
30525951
Citation
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.
Results Reference
derived
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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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