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

AB Biotek

Status and phase: Completed; Early Phase 1

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

Treatments: Dietary Supplement: ABB S3; Dietary Supplement: Placebo; Dietary Supplement: ABB C22

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06738420

2022-003423-18

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

ABB S3 - active

Experimental group

Description:

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

Treatment:

Dietary Supplement: ABB S3

ABB S3 - Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Placebo

ABB C22 - active

Experimental group

Description:

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

Treatment:

Dietary Supplement: ABB C22

ABB C22 - placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Placebo