Safety and Efficacy of a Probiotic Supplement in IBS-D (NCT05754177) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of a Probiotic Supplement in IBS-D
Slovenia46 participantsStarted 2023-06-06
Plain-language summary
This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
* Males and females aged ≥18 to ≤ 65 years.
* Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
i) Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria:
* Related to defecation
* Associated with a change in stool frequency (increase/decrease in frequency).
* Associated with a change in the form (appearance) of stool. ii) History of abnormal bowel movements predominantly diarrhoea (\>25% of bowel movements categorised as stool form type 6 or 7 (diarrhoea) and \<25% as stool form type 1 or 2 (constipation) on BSFS).
* Participants with an IBS-SSS score ≥ 175.
* Participants who test negative for COVID-19 by Rapid Antigen Test Device.
* Participants who did not change their diet within three months before the screening day and are willing to sustain that diet during the study.
* Participants who can comply and perform the procedures as per the protocol (consumption of study products, biological sample collection procedures, and study visit schedule).
* Participants who are literate enough to understand the purpose of the study and their rights.
* Participants who are able to give written informed consent and are willing to participate in the study.
Exclusion criteria
* Participants who score ≥ 40 in either the 'state' or 'trait' section of the STAI-AD questionnaire (both sections to be assessed).
* Participa…
What they're measuring
1
Change in total irritable bowel syndrome symptom severity score (IBS-SSS)