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Background: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms.
Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| To assess the effect of multistrain probiotics on abdominal | Placebo Comparator | To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients. |
|
| To assess the efficacy of a multistrain probiotic supplement | Placebo Comparator | To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula Capsule | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo | The change in severity and frequency of abdominal pain as measured by IBS-Symptom Severity Scores during treatment with a multi-strain probiotic or placebo, and compared with baseline. | 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashton Harper, MRCS | Probiotics International Ltd (Protexin) | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29801486 | Derived | Ishaque SM, Khosruzzaman SM, Ahmed DS, Sah MP. A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult(R)) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterol. 2018 May 25;18(1):71. doi: 10.1186/s12876-018-0788-9. |
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After completion of paper.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2015 | Aug 2, 2017 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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a randomized, double-blind, placebo-controlled clinical trial
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Participants divided into two groups by randomization software, consisting of 200 in each group.
| D004066 | Digestive System Diseases |