Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03318614
Other study ID # USM/JEPeM/15040133
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received October 12, 2017
Last updated October 18, 2017
Start date September 2015
Est. completion date December 2015

Study information

Verified date October 2017
Source University of Science Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Science Malaysia Morinaga Milk Industry Co. Ltd., Japan

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Three months
Secondary 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. Three months
Secondary 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. Three months
Secondary 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. Three months
Secondary 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. Three months
See also
  Status Clinical Trial Phase
Completed NCT03720314 - Microbiota Profiling in IBS
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT05213910 - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains N/A
Recruiting NCT05985018 - Traditional Dietary Advice Vs. Mediterranean Diet in IBS N/A
Completed NCT04486469 - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. N/A
Completed NCT06407609 - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS N/A
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04145856 - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico Phase 4
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Not yet recruiting NCT05157867 - In Vivo Effects of Amylase Trypsin Inhibitors N/A
Not yet recruiting NCT05100719 - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION) N/A
Recruiting NCT05001997 - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome N/A
Recruiting NCT02953171 - Probiotics in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT02977975 - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT03266068 - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed NCT02980406 - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level N/A
Recruiting NCT02242175 - Efficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome N/A