Signs and Symptoms, Digestive Clinical Trial
Official title:
Fiber Tolerability in Children
Assessment of the digestive tolerability of the PROMITOR® .
The trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm
parallel-design. The subjects wil be randomized to one of the four arms, i.e. four doses of
investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g
(corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of
the evening versus control (maltodextrin, no fibers) over one week of intake.
The total sample size is 40 healthy children from 8 to 12 years old, male and female.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02530762 -
Acute Gastrointestinal Tolerability Following a Single Serving of a Novel Dietary Fiber
|
N/A | |
| Completed |
NCT02532985 -
Gastrointestinal Tolerability Following Multiple Servings of a Novel Dietary Fiber
|
N/A | |
| Recruiting |
NCT01464814 -
Clinical Trial Evaluating the Viability of L. Casei + Fish Oil Capsules
|
N/A | |
| Completed |
NCT02180035 -
Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS
|
N/A | |
| Completed |
NCT05603403 -
Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
|
Phase 4 | |
| Recruiting |
NCT02928484 -
Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function
|
Phase 1/Phase 2 | |
| Completed |
NCT02677090 -
Fiber Tolerability in Children Aged 3-7 Year
|
N/A | |
| Completed |
NCT00822328 -
Fermented Milk Drink on Human Intestinal Microflora
|
Phase 2 | |
| Completed |
NCT02253628 -
The Acute Effect of Coffee Consumption on Stomach, Self-reported Gastrointestinal Symptoms and Stress.
|
N/A | |
| Completed |
NCT00251914 -
Nexium Dyspepsia/AST
|
Phase 3 | |
| Completed |
NCT00251992 -
Nexium Dyspepsia/AST
|
Phase 3 | |
| Completed |
NCT01431482 -
Evaluation of the Composition of Human Milk and Health Outcomes in Children
|
||
| Terminated |
NCT01675960 -
Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
|
Phase 2 | |
| Completed |
NCT00652834 -
Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
|
Phase 4 | |
| Active, not recruiting |
NCT00110708 -
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
|
Phase 2 |