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
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Abdominal Pain Small Intestinal Bacterial Overgrowth||Dietary Supplement: Probiotics M-63 Other: Control group||Phase 2 Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|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|
|Official Title:||Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
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.
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.
Other: Control group
No probiotic intervention was given to the control group for three months.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318614
|Principal Investigator:||Yeong Yeh Lee, MD, PhD||University of Science Malaysia|