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

NCT05348642 | Completed

• 1 other identifier: A-M/001322-2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to day 14, day 42 and day 84

Secondary Outcomes (6)

• Irritable Bowel Syndrome-Global Improvement Scale / IBS-GIS

  From baseline to day 14, day 42 and day 84

• 3-day diary data on stool frequency

  From baseline to day 84

• 3-day diary data on stool consistency (Bristol Stool Form Scale / BSFS)

  From baseline to day 14, day 42 and day 84

• Hospital Anxiety and Depression Scale / HADS

  From baseline to day 14, day 42 and day 84

• SF-12: 12-item Short Form survey

  From baseline to day 42 and day 84

Study Arms (2)

Experimental group receiving pasteurized Akkermansia muciniphila

EXPERIMENTAL

pasteurized Akkermansia muciniphila - daily oral dose

Dietary Supplement: pasteurized A. muciniphila

Control group

PLACEBO COMPARATOR

Control group receiving placebo, identical to verum regarding the form, size, taste, color and intake.

Dietary Supplement: placebo

Interventions

pasteurized A. muciniphila DIETARY_SUPPLEMENT

pasteurized A. muciniphila - oral daily dose

Experimental group receiving pasteurized Akkermansia muciniphila

placebo DIETARY_SUPPLEMENT

Placebo = identical to verum regarding the form, size, taste, color and intake

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women from 18 to 70 years old
• Meeting Rome-IV criteria for IBS:
• Recurrent abdominal pain on average ≥1 day/ week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria:
• Related to defecation
• Associated with a change in frequency of stool
• Associated with a change in form (appearance) of stool
• Consistent and stable body weight in the last 3 months prior to study (less than 5% self-reported change)
• Having access to a smartphone or a computer with an internet access, either allowing a video call, and familiar with the use thereof (checked during the visit)
• Subject's agreement to comply with study procedures, in particular:
• to take IP as recommended
• to avoid the use of other products which may influence the GI complaints during the study
• to keep the habitual dietary habits, type and level of physical activity (including any specific exercise such as e.g. yoga) as well as the level of caffeine or nicotine (if any)
• to complete the subject diary and study questionnaires
• Women of childbearing potential:
• commitment to use contraception methods

You may not qualify if:

• Self-reported known allergy or hypersensitivity to any of the components of the investigational product
• Self-reported nocturnal GI complaints
• Women of childbearing potential: self-reported GI complaints mainly related to menstruation
• Self-reported lactose or fructose intolerance
• Self-reported acute or chronic significant GI disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis, disorders in digestive tract motility etc.)
• Self-reported local anorectal problems (e.g. anal fissure, bleeding haemorrhoids)
• Self-reported clinically significant findings in colonoscopy within the 2 years prior to study
• Family history (immediate family) of colorectal cancer or inflammatory bowel disease; anxiety or depression requiring medication
• Acute or chronic psychiatric disease (e.g. depression, anxiety, bipolar disorder) requiring medication
• History and/or presence of other clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
• unstable thyroid gland disorder
• unstable hypertension
• unstable diabetes mellitus
• eating disorder
• immunodeficiency

Sponsors & Collaborators

• A-Mansia Biotech S.A.: lead

Study Sites (1)

analyze & realize GmbH

Berlin, 13467, Germany

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Study Director

  A-Mansia Biotech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment randomized, double-blind, placebo-controlled, parallel group, single center trial

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 27, 2022
• Study Start: July 21, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

DE (1)