Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial

Early Phase 1

Completed

• Conditions: Constipation

• Registration Number: NCT06738433
• Lead Sponsor: AB Biotek

Brief Summary

In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Primary Completion: 2024-04-04
• Study Completion: 2024-04-04
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Subjects who require hospitalization
• Constipation defined as the Rome IV criteria for constipation
• Patients with the ability to take the study product orally

Exclusion Criteria

• History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
• History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
• Patients last palliative care en stage of "end of life" or "terminal"
• Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
• Laxatives
• Antibiotic treatment in the previous 2 weeks
• Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Microbiota composition	from baseline to day 14 of supplementation	Changes in microbiota composition through Shanon diversity test and statistical analyses (Continuous variables will be described as mean and standard deviation (SD) or as median and interquartile range; and categorical variables such as absolute frequencies and percentages).

Secondary Outcome Measures

Name	Time	Method
Transit time	from baseline to day 14 of supplementation	transit time measured as methane on breathe testing
Tolerance and gastro-intestinal comfort	from baseline to day 14 of supplementation	Tolerance and gastro-intestinal comfort (validated questionnaires) life questionnaire: the Digestion-associated Quality of Life Questionnaire (DQLQ)
Brain Derived Neurotrophic Factor (BDNF)	from baseline to day 14 of supplementation	levels of Brain Derived Neurotrophic Factor (BDNF) (pg/mL)

Trial Locations

Locations (1)

Isabel Roig; 🇸🇸 Barcelona, South Sudan

Isabel Roig

🇸🇸Barcelona, South Sudan