Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders
NCT ID: NCT06738420
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2023-01-27
2024-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
ABB S3
Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
ABB S3 - Placebo
Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
Placebo
Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
ABB C22 - active
Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration
ABB C22
Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration
ABB C22 - placebo
Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration
Placebo
Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration
Interventions
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ABB S3
Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
ABB C22
Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration
Placebo
Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
Placebo
Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Colisée Barcelona Isabel Roig
UNKNOWN
Grupo Colisée
UNKNOWN
AB Biotek
INDUSTRY
Responsible Party
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Locations
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Isabel Roig
Barcelona, Barcelona, Spain
Countries
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References
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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.
Other Identifiers
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2022-003423-18
Identifier Type: -
Identifier Source: org_study_id
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