NCT05348642

Study to Evaluate the Effect of Pasteurized Akkermansia Muciniphila (pAkk) on Complaints Related to IBS

Study to Evaluate the Effect of Pasteurized Akkermansia Muciniphila (pAkk) on Complaints Related to Irritable Bowel Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: A-Mansia Biotech S.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	pasteurized A. muciniphila	pasteurized A. muciniphila - oral daily dose
DIETARY_SUPPLEMENT	placebo	Placebo = identical to verum regarding the form, size, taste, color and intake

Timeline

• Start date: 2022-07-21
• Primary completion: 2023-01-06
• Completion: 2023-01-06
• First posted: 2022-04-27
• Last updated: 2023-03-02

Locations

1 site across 1 country: Germany