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Irritable Bowel SyndromePhase 2/3NCT03318614

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

A Phase 2/3 study testing Probiotics M-63 in people with Irritable Bowel Syndrome and Abdominal Pain, run by Universiti Sains Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Probiotics M-63
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
No sites listed yet
Study dates
Sep 2015to Dec 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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.

Read the 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.

Being tested
Probiotics M-63, Control group
Keywords
Gut Microbiota, Probiotics, Abdominal Pain, Small Intestinal Bacterial Overgrowth, Mental
Medical subject headings
Irritable Bowel Syndrome, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotics M-63Dietary supplement

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

  • Control groupOther

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

Study groups in NCT03318614
Study groupRoleWhat they receive
Probiotics M-63 groupExperimentalParticipants 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.
Receives: Dietary Supplement: Probiotics M-63
Control groupPlacebo comparatorNo probiotic intervention was given to the control group over three months other than advice of good hygiene and sanitation practices.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three months

Secondary outcomes (4)

  1. 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.

    Measured: Three months

  2. 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.

    Measured: Three months

  3. 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.

    Measured: Three months

  4. 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.

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2017
  2. Study startSep 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03318614
Sponsor's protocol ID
USM/JEPeM/15040133
Status last verified
Oct 2017
First submitted
12 Oct 2017
Last updated
24 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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.

    PubMed 30525951

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Probiotics M-63 in people with Irritable Bowel Syndrome and Abdominal Pain, run by Universiti Sains Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IBS Symptom Severity Scale (IBS-SSS) scores (time frame: Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03318614, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.

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