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

NCT ID: NCT06738433

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2024-04-04

Brief Summary

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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

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Conditions

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Constipation

Keywords

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constipation prebiotic postbiotic gastrointestinal dietary supplement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABB i5

Prebiotic ABB i5 (NextDext®, 5g)

Group Type EXPERIMENTAL

ABB i5

Intervention Type DIETARY_SUPPLEMENT

Prebiotic ABB i5 (NextDext®, 5g)

ABB C24

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

Group Type EXPERIMENTAL

ABB C24

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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ABB i5

Prebiotic ABB i5 (NextDext®, 5g)

Intervention Type DIETARY_SUPPLEMENT

ABB C24

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Colisée

UNKNOWN

Sponsor Role collaborator

AB Biotek

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Isabel Roig

Barcelona, Barcelona, South Sudan

Site Status

Countries

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South Sudan

References

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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.

Reference Type DERIVED
PMID: 40780410 (View on PubMed)

Other Identifiers

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ABB i5/ABB C24

Identifier Type: -

Identifier Source: org_study_id