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

Early Phase 1

Completed

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

• Registration Number: NCT06738420
• Lead Sponsor: AB Biotek

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-27
• Primary Completion: 2024-03-06
• Study Completion: 2024-04-04
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Faecal calprotectin	from baseline to day 14 of supplementation	reduction in faecal calprotectin levels (mg/g)
faecal lactoferrin	from baseline to day 14 of supplementation	reduction 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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Isabel Roig; 🇪🇸 Barcelona, Spain