Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders

NCT06738420 | Completed

• 1 other identifier: 2022-003423-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial

Conditions

Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy; Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition

Keywords

diarrhoea; postbiotic; adults

Outcome Measures

Primary Outcomes (3)

• Faecal calprotectin

  change in faecal calprotectin levels (mg/g)

  from baseline to day 14 of supplementation

• faecal lactoferrin

  change in the number of participants with a positive "faecal lactoferrin" result (%)

  from baseline to day 14 of supplementation

• Blood IgAs

  levels of serum IgAs (mg/dL)

  from baseline to day 14 of supplementation

Secondary Outcomes (2)

• Gastrointestinal symptoms

  from baseline to day 14 of supplementation

• faecal consisitency

  from baseline to day 14 of supplementation

Study Arms (4)

ABB S3 - active

EXPERIMENTAL

Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition

Dietary Supplement: ABB S3

ABB S3 - Placebo

PLACEBO COMPARATOR

Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition

Dietary Supplement: Placebo

ABB C22 - active

EXPERIMENTAL

Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration

Dietary Supplement: ABB C22

ABB C22 - placebo

PLACEBO COMPARATOR

Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration

Dietary Supplement: Placebo

Interventions

ABB S3 DIETARY_SUPPLEMENT

Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition

ABB S3 - active

ABB C22 DIETARY_SUPPLEMENT

Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration

ABB C22 - active

Placebo DIETARY_SUPPLEMENT

Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition

ABB S3 - Placebo

Eligibility Criteria

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

You may qualify if:

• Inpatients of the centre
• Diagnostic of diarrhoea: increase in daily faecal weight \> 200 g (as per the Centre protocol).
• Subjects who as per the Centre protocol require Oral rehydration therapy
• 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 in situation of last days
• Amytriptilin and masalazine treatment (anti-depressives)
• Laxatives

Sponsors & Collaborators

• AB Biotek: lead
• Colisée Barcelona Isabel Roig: collaborator
• Grupo Colisée: collaborator

Study Sites (1)

Isabel Roig

Barcelona, Barcelona, 0803', Spain

Location

Related Publications (1)

• Mateus Rodriguez JA, Rodriguez Sanz P, Kostandyan E, Palacios Sanchez R, Pino Roque ML, Chaves Vasquez P, Roy Millan P. Mitigating Diarrhoea-Related Inflammation in Frail Older Adults with Postbiotic-Enhanced Oral Rehydration Solution: Insights from a Randomised, Double-Blind, Placebo-Controlled Study. Geriatrics (Basel). 2025 Mar 1;10(2):34. doi: 10.3390/geriatrics10020034.

  PMID: 40126284 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: January 27, 2023
• Primary Completion: March 6, 2024
• Study Completion: April 4, 2024
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

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

Locations

ES (1)