Constipation, Functional Gastrointestinal Disorders
Conditions
Keywords
constipation, dyspepsia
Brief summary
We will conduct a 2 months clinical intervention in which a 20 g appled derived fibre supplement will be compared with a placebo without fibre. The main outcome will be the reduction in the Gastrointestinal System Rating Scale
Detailed description
Participants with constipation and mild gastrointestinal symptoms will be invited to participate. Those with alarming symptoms such as gastrointestinal bleeding or weight loss, those using laxatives or medications with anticholinergic actions will be excluded from the study At baseline, participants will be weighed and interrogated about Their gastrointestinal symptoms using the Gastrointestinal symptom rating scale Their type of stools using the Bristol visual stool scale The number of complete spontaneous bowel movements per week Afterwards, they will be randomized, balancing by age, gender and body mass index to receive in a doubly blind fashion A 20 g/day powder with apple derived fiber A similarly looking placebo powder The intervention will last 8 weeks. Every two weeks, participants will be cited to provide a new supply of the product, retrieve the used vials and be interrogated using the same tools as baseline. At the end of the intervention, participants will be weighed again
Interventions
This is a combination of soluble and insoluble fiber
Sponsors
Study design
Masking description
Active product and placebo will have the same appearance. All vials will have an unique numerical code
Intervention model description
Double blind parallel study comparing a fiber supplement with a fiberless placebo
Eligibility
Inclusion criteria
* presence of constipation or functional gastrointestinal symptoms
Exclusion criteria
having serious cardiovascular, kidney or hepatic diseases * gastrointestinal bleeding weight loss use of laxatives use of medications with anticholinergic actions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptom rating scale | every 2 weeks during 8 weeks | This scale assesses abdominal pain, bloating and type of stools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of complete spontaneous bowel movements per week | every 2 weeks during 8 weeks | the title is auto-explicative |
Countries
Chile