The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial.
Trials
; 19(1): 256, 2018 Apr 27.
Article
en En
| MEDLINE
| ID: mdl-29703235
ABSTRACT
BACKGROUND:
Constipation is a frequent problem in adults with Prader-Willi syndrome. Certain probiotics have been shown to improve transit and gastrointestinal symptoms of adults with functional constipation. The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp. lactis B94 (B. lactis B94) on stool frequency, stool form, and gastrointestinal symptoms in adults with Prader-Willi syndrome.METHODS:
Adults with Prader-Willi syndrome (18-75 years old, n = 36) will be recruited and enrolled in a 20-week, randomized, double-blind, placebo-controlled, crossover study. Study subjects will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Subjects will complete daily records of stool frequency and stool form (a proxy of transit time). Dietary intake data also will be collected. Stools, one in each period, will be collected for exploratory microbiota analyses.DISCUSSION:
To our knowledge, this is the first randomized controlled trial evaluating the effectiveness of B. lactis in adults with Prader-Willi syndrome. The results of this study will provide evidence of efficacy for future clinical trials in patient populations with constipation. TRIAL REGISTRATION ClinicalTrials.gov ( NCT03277157 ). Registered on 08 September 2017.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
/
3_ND
Problema de salud:
1_doencas_nao_transmissiveis
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3_zoonosis
Asunto principal:
Síndrome de Prader-Willi
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Estreñimiento
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Probióticos
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Defecación
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Microbioma Gastrointestinal
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Bifidobacterium animalis
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Intestinos
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Límite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2018
Tipo del documento:
Article
País de afiliación:
Estados Unidos