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

NCT06738433 | Completed Early Phase 1

• 1 other identifier: ABB i5/ABB C24
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

constipation; prebiotic; postbiotic; gastrointestinal; dietary supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Transit time

  from baseline to day 14 of supplementation

• Tolerance and gastro-intestinal comfort

  from baseline to day 14 of supplementation

• Brain Derived Neurotrophic Factor (BDNF)

  from baseline to day 14 of supplementation

Study Arms (2)

ABB i5

EXPERIMENTAL

Prebiotic ABB i5 (NextDext®, 5g)

Dietary Supplement: ABB i5

ABB C24

EXPERIMENTAL

ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g

Dietary Supplement: ABB C24

Interventions

ABB i5 DIETARY_SUPPLEMENT

Prebiotic ABB i5 (NextDext®, 5g)

ABB i5

ABB C24 DIETARY_SUPPLEMENT

ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g

ABB C24

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AB Biotek: lead
• Grupo Colisée: collaborator

Study Sites (1)

Isabel Roig

Barcelona, Barcelona, 08030, South Sudan

Location

Related Publications (1)

• Culqui Levano DR, Rodriguez Sanz P, Palacios Sanchez R, Saldana Miranda MY, Santa Cruz Lopez CY, Mateus Rodriguez JA. Impact of prebiotics and postbiotics in the management of constipation: Analysis of their differentiated modulation of intestinal microbiota. Clin Nutr ESPEN. 2025 Oct;69:625-633. doi: 10.1016/j.clnesp.2025.08.003. Epub 2025 Aug 6.

  PMID: 40780410 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 17, 2024
• Study Start: April 25, 2023
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: According to legislation

Locations

SO (1)