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)

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: ABB i5; Dietary supplement: ABB C24

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• South Sudan
  • Barcelona, South Sudan, 08030
    • Isabel Roig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABB i5; Prebiotic ABB i5 (NextDext®, 5g)	Dietary supplement: ABB i5; Prebiotic ABB i5 (NextDext®, 5g)
Experimental: ABB C24; ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g	Dietary supplement: ABB C24; ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota composition	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).	from baseline to day 14 of supplementation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AB Biotek
• Collaborators: Grupo Colisée

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: prebiotic; dietary supplement; postbiotic; constipation; gastrointestinal
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: ABB i5/ABB C24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Statistical results on microbiological data.
• IPD Sharing Time Frame: According to legislation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No