Influence of Modern Colon Hydrotherapy on Intestinal Transit

Not Applicable

Not yet recruiting

• Conditions: Constipation - Functional; Functional Colonic Diseases; Hydrotherapy
• Interventions: Other: Modern Colon Hydrotherapy plus probiotic product intake

• Registration Number: NCT06438068
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

A randomised and controlled trial, in which the effect of Modern Colon Hydrotherapy is evaluated in the gastrointestinal transit of subjects with functional constipation

Detailed Description

The aim of the present randomized randomised and controlled trial is to evaluate the effect of Modern Colon Hydrotherapy in the gastrointestinal transit of subjects with functional constipation.

Two intervention groups were used, to which this type of treatment was applied and to which the intake of a product with prebiotic and prebiotic properties or a placebo was added, depending on the assigned group.

Study Timeline

• Study First Submitted: 2024-05-26
• Study First Submitted QC: 2024-05-26
• Study First Posted: 2024-05-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Study Start: 2024-09
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution.

Exclusion Criteria

• Taking any type of antibiotic in the last month
• Taking prebiotics or probiotics products in the last month.
• Taking laxatives in the last month.
• Undergoing any medicinal treatment
• Pregnancy
• Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modern Colon Hydrotherapy plus placebo intake	Modern Colon Hydrotherapy plus probiotic product intake	Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days.
Modern Colon Hydrotherapy plus probiotic product intake	Modern Colon Hydrotherapy plus probiotic product intake	Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days.

Primary Outcome Measures

Name	Time	Method
intestinal transit	7 days	intestinal transit using radiopaque markers

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain