Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial (ABB i5/ABB C24)

AB Biotek

Status and phase

Completed

Early Phase 1

Conditions

Constipation

Treatments

Dietary Supplement: ABB i5

Dietary Supplement: ABB C24

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06738433

ABB i5/ABB C24

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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