Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders (ABB S3/ABB C22)

Efficacy and Tolerability of a Nutritional Supplementation With Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders: a Pilot Trial

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

Study Overview

• Status: Completed
• Conditions: Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy; Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition
• Intervention / Treatment: Dietary supplement: ABB S3; Dietary supplement: Placebo; Dietary supplement: Placebo; Dietary supplement: ABB C22

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 0803'
      • Isabel Roig

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

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 in situation of last days
  • Amytriptilin and masalazine treatment (anti-depressives)
  • Laxatives

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABB S3 - active; 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; Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
Placebo Comparator: ABB S3 - Placebo; Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition	Dietary supplement: Placebo; Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition; Dietary supplement: Placebo; Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration
Experimental: ABB C22 - active; Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration	Dietary supplement: ABB C22; Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration
Placebo Comparator: ABB C22 - placebo; Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration	Dietary supplement: Placebo; Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition; Dietary supplement: Placebo; Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood IgAs	levels of serum IgAs (mg/dL)	from baseline to day 14 of supplementation
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal symptoms	assessment of number of diarrhea, vomits and regurgitation events	from baseline to day 14 of supplementation
faecal consisitency	assessed through Bristol scale (1-7 score)	from baseline to day 14 of supplementation

Collaborators and Investigators

• Sponsor: AB Biotek
• Collaborators: Grupo Colisée; Colisée Barcelona Isabel Roig

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Actual): March 6, 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): December 17, 2024

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: diarrhoea; adults; postbiotic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Diarrhea
• Other Study ID Numbers: 2022-003423-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Biomarkers data (calprotectin, lactoferrin, igA) data, Bristol scale 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