Constipation - Functional
Conditions
Keywords
Constipation, Fiber
Brief summary
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence: * Group A: study product+wash out+control product * Group B: control product+wash out+study product
Detailed description
All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out. * Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber. * Control: Placebo supplement: maltodextrin and plum flakes
Interventions
DIETARY_SUPPLEMENTMixture of fibers + Placebo
Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)
DIETARY_SUPPLEMENTPlacebo + Mixture of fibers
Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)
Sponsors
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Boys and girls aged 3 to 12 * Diagnosis of functional constipation according to Rome IV criteria
Exclusion criteria
* Regular use of a dietary fiber supplement, prebiotics or probiotics in the previous 30 days, or who would have been taking bulk-forming agents or laxatives in the 2 weeks prior to the study * Use of medications that cause constipation * Children with organic constipation such as Hirschsprung's disease, cerebral paralysis, anorectal and spinal cord abnormalities and metabolic diseases. * Patients who are not likely to complete follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool. | From baseline to 8 weeks | Combined score between this parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consistency of stool according to Bristol Stool Form Scale | From baseline to 8 weeks | Valuation of stool characteristics (Bristol scale): 7 types of consistency, where type 1 is the hardest consistency. |
| Frequency of stool | From baseline to 8 weeks | Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week |
| Change in stool weight | From baseline to 8 weeks | Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15% |
| Gastrointestinal symptoms related to the constipation | From baseline to 8 weeks | Record in the patient's dairy all the gastrointestinal symptoms during the study |
| Adherence record to the complement intake (Moriski Green test) | At 8 weeks | 4 questions to the patient about treatment adherence.Patients who follow treatment are considered to be those who answer NO to the four questions and not to those who answer YES to one or more. |
| Patient anthropometric measures: weight | Up to 8 weeks | Anthropometric records: weight (Kg) |
| Patient anthropometric measures: size | Up to 8 weeks | Anthropometric records: size (cm) |
| Patient anthropometric measures: waist perimeter | Up to 8 weeks | Waist perimeter (cm) |
Countries
Spain
Contacts
Primary ContactRoser De Castellar, MD
Outcome results
None listed