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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06738420

Acronym

ABB S3/ABB C22

Enrollment

100

Registered

2024-12-17

Start date

2023-01-27

Completion date

2024-04-04

Last updated

2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

diarrhoea, postbiotic, adults

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

Interventions

DIETARY_SUPPLEMENTPlacebo

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

DIETARY_SUPPLEMENTABB S3

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

DIETARY_SUPPLEMENTABB C22

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Faecal calprotectin	from baseline to day 14 of supplementation	change in faecal calprotectin levels (mg/g)
faecal lactoferrin	from baseline to day 14 of supplementation	change in the number of participants with a positive faecal lactoferrin result (%)
Blood IgAs	from baseline to day 14 of supplementation	levels of serum IgAs (mg/dL)

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026