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NCT06438068 Clinical Trial

Influence of Modern Colon Hydrotherapy on Intestinal Transit

Constipation - Functional Clinical Trial

Official title:
Influence of Modern Colon Hydrotherapy on Intestinal Transit

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06438068
Other study ID # UComplutenseMadrid Fasisifer3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 26, 2024
Est. completion date July 15, 2024

Study information
Verified date May 2024
Source Universidad Complutense de Madrid
Contact Isidro Fernández-López, PhD.
Phone 34625598970
Email isidrofe@ucm.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date July 15, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Modern Colon Hydrotherapy plus probiotic product intake
Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy separated by 48 hours. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days.

Locations
Country Name City State
Spain Universidad Complutense de Madrid Madrid

Sponsors (1)
Lead Sponsor Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary intestinal transit intestinal transit using radiopaque markers 7 days
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