Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics

NCT06381193 | Completed

• 1 other identifier: ESTR-01-2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
• To evaluate the stool consistency after 8 weeks (Bristol scale).
• To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks. Participants are randomized into the following groups:
• Group A: 20 assigned to probiotic + placebo
• Group B: 20 assigned to prebiotic + placebo
• Group C: 20 assigned to probiotic + prebiotic
• Group D: 20 assigned to the placebo + placebo Participants took 4 units of product per day (2 of each assigned product) for 2 months.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

• 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation.

  8 weeks

Secondary Outcomes (3)

• To evaluate the stool consistency (Bristol scale).

  8 weeks

• To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20)

  8 weeks

• To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale).

  8 weeks

Study Arms (4)

Group A

EXPERIMENTAL

Dietary Supplement: Probiotic

Group B

EXPERIMENTAL

Dietary Supplement: Prebiotic

Group C

EXPERIMENTAL

Dietary Supplement: Probiotic + Prebiotic

Group D

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

oral, daily

Group A

Prebiotic DIETARY_SUPPLEMENT

oral, daily

Group B

Probiotic + Prebiotic DIETARY_SUPPLEMENT

oral, daily

Group C

Placebo DIETARY_SUPPLEMENT

oral, daily

Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Excessive straining at least in 25% of bowel movements.
• Hard stools (types 1-2 on the Bristol scale) at least in 25% of stools.
• Sensation of incomplete evacuation at least in 25% of the stools.
• Sensation of anorectal obstruction or blockage at least in 25% of bowel movements.
• Manual maneuvers to facilitate defecation at least in 25% of stools.
• Less than three complete spontaneous bowel movements per week.
• 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:
• Related to defecation.
• Associated with change in stool frequency.

You may not qualify if:

• Minors under 18 or over 65 years of age.
• Patients diagnosed with other chronic diseases ( Parkinson's or other dementias, cerebral palsy, heart attack, tetraplegia, hemiplegia, intellectual disability, multiple sclerosis, amyotrophic lateral sclerosis (ALS), cystic fibrosis, congenital metabolic diseases, eating disorders).
• With previous surgeries in the gastrointestinal tract.
• Patients with scheduled surgical interventions during the study.
• Patient treated with anticoagulants.
• Patients who have used laxative treatment during the 15 days before the start of the study.
• Patients who have been treated with antibiotics in the last month.
• Usual treatment with opioid analgesics.
• Patients diagnosed or with sufficient criteria for the diagnosis of ulcerative colitis, Crohn's disease, presence of intestinal obstruction or malignant disease in the gastrointestinal tract.
• Participation in another clinical trial with an investigational medication 30 days before the start of the study.
• Pregnant or breastfeeding women.
• Patients with hypersensitivity, allergy or intolerance to any of the components of the food supplements in the study

Sponsors & Collaborators

• Centros de Investigación de Nutrición y Salud: lead
• Nutribiotica: collaborator

Study Sites (1)

Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA)

Madrid, 28036, Spain

Location

MeSH Terms

Interventions

Probiotics; Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: March 3, 2023
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

ES (1)