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Completed

NCT Number: NCT06738420

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

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

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Key information

Conditions

Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy Diarrhea Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isabel Roig

Barcelona, 0803', Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 C22

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Faecal calprotectin

    Time frame: from baseline to day 14 of supplementation

    change in faecal calprotectin levels (mg/g)

  2. faecal lactoferrin

    Time frame: from baseline to day 14 of supplementation

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

  3. Blood IgAs

    Time frame: from baseline to day 14 of supplementation

    levels of serum IgAs (mg/dL)

Secondary outcomes

  1. Gastrointestinal symptoms

    Time frame: from baseline to day 14 of supplementation

    assessment of number of diarrhea, vomits and regurgitation events

  2. faecal consisitency

    Time frame: from baseline to day 14 of supplementation

    assessed through Bristol scale (1-7 score)

Sponsors and collaborators

Lead sponsor

AB Biotek

Industry

Collaborators

  • Colisée Barcelona Isabel Roig
  • Grupo Colisée

Registry information

Official study title

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

Acronym: ABB S3/ABB C22

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2024
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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