Double-blind, randomised, placebo-controlled study to evaluate the benefit of pasteurized Akkermansia muciniphila in reducing complaints related to irritable bowel syndrome. Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and tolerability.
Irritable bowel syndrome (IBS) is one of the most common disorders of gut-brain interaction, globally affecting about 10% of the population. Typical predominant traits are abdominal pain and abnormal bowel habits. The use of probiotics in IBS has been continuously assessed; in recent systematic reviews and meta-analyses, single or combined probiotic strains were indicated to have beneficial effects and good tolerability in the affected population. pAkk has recently been assessed as a safe novel food ingredient. Beneficial effects and very good tolerability of pAkk have been reported in individuals with metabolic disorders. The objective of the present clinical study - a double-blind, randomised, placebo-controlled, parallel group design, explorative pilot 12-week nutritional study, is to assess the potential of pAkk in IBS management. The main study objective is then to evaluate the benefit of pAkk in reducing complaints related to irritable bowel syndrome. Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and tolerability. In total, 90 participants will be enrolled and will attend 4 study visits: one on site and 3 televisits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
pasteurized A. muciniphila - oral daily dose
Placebo = identical to verum regarding the form, size, taste, color and intake
analyze & realize GmbH
Berlin, Germany
Irritable Bowel Severity Scoring System / IBS-SSS
Changes at each timepoint of assessment in comparison to baseline. IBS-SSS is between 0 and 500, with a higher score meaning more severe symptoms.
Time frame: From baseline to day 14, day 42 and day 84
Irritable Bowel Syndrome-Global Improvement Scale / IBS-GIS
Changes at each timepoint of assessment in comparison to baseline. The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "How would you rate your IBS signs or symptoms over the past 7 days": Subjects respond on a scale of 1-7 where: 1 = Significantly relieved, 2 = Moderately relieved, 3 = Slightly relieved, 4 = Unchanged, 5 = Slightly worse, 6 = Moderately worse, 7 = Significantly worse.
Time frame: From baseline to day 14, day 42 and day 84
3-day diary data on stool frequency
Changes at each timepoint of assessment in comparison to baseline
Time frame: From baseline to day 84
3-day diary data on stool consistency (Bristol Stool Form Scale / BSFS)
Changes at each timepoint of assessment in comparison to baseline. The Bristol Stool Form Scale is a 7 score visual scale to measure stool consistency. (1) Separate hard lumps like nuts (difficult to pass); (2) Sausage-shaped but lumpy; (3) Like a sausage but with cracks on its surface; (4) Like a sausage or snake, smooth and soft; (5) Soft blobs with clear-cut edges (passed easily); (6) Fluffy pieces with ragged edges, a mushy stool; (7) Watery, no solid pieces, entirely liquid.
Time frame: From baseline to day 14, day 42 and day 84
Hospital Anxiety and Depression Scale / HADS
Changes at each timepoint of assessment in comparison to baseline. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
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Time frame: From baseline to day 14, day 42 and day 84
SF-12: 12-item Short Form survey
Changes at each timepoint of assessment in comparison to baseline. The SF-12 consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Time frame: From baseline to day 42 and day 84
Global evaluation of tolerability by subject and investigator
Changes in comparison to baseline. 8 weeks after the baseline, the subjects and the investigator will rate the tolerability of the IP by means of a global scaled evaluation with "very good", "good", "moderate" and "poor"
Time frame: From baseline to day 84