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| Name | Class |
|---|---|
| Nutribiotica | UNKNOWN |
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The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:
Participants are randomized into the following groups:
Participants took 4 units of product per day (2 of each assigned product) for 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | oral, daily |
| |
| Prebiotic |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the stool consistency (Bristol scale). | Type 1-7 (types 3 and 4 indicate a regular transit) | 8 weeks |
| To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20) |
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Inclusion Criteria:
Men or women between 18-65.
BMI 18.5-39.9 kg/m2
According to the ROME IV criteria, patients with functional constipation who meet the following conditions for at least the last three months and with symptoms for at least 6 months before diagnosis:
The presence of two or more of the following criteria:
Diarrhea rarely occurs without the use of laxatives.
Insufficient criteria for the diagnosis of irritable bowel syndrome.
Or, according to the ROME IV criteria, patients who suffer from constipation type irritable bowel syndrome defined as a syndrome in which there is abdominal pain with at least two of the following three characteristics:
Patients who have signed the informed consent.
Patients with the ability to understand and carry out the study procedures.
Women participating in the study must meet one of these two conditions:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centros de Investigación en Nutrición y Salud SL. (ClÃnica CINUSA) | Madrid | 28036 | Spain |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Dietary Supplement |
oral, daily |
|
| Probiotic + Prebiotic | Dietary Supplement | oral, daily |
|
| Placebo | Dietary Supplement | oral, daily |
|
| 8 weeks |
| To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale). | 8 weeks |
| D019602 |
| Food and Beverages |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |