Influence of Modern Colon Hydrotherapy on Intestinal Transit

NCT ID: NCT06438068

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Constipation - Functional Hydrotherapy Functional Colonic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Modern Colon Hydrotherapy plus probiotic product intake

Intervention Type OTHER

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.

Modern Colon Hydrotherapy plus placebo intake

Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days.

Group Type ACTIVE_COMPARATOR

Modern Colon Hydrotherapy plus probiotic product intake

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Isidro Fernández López

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isidro Fernández-López, PhD.

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Universidad Complutense de Madrid

Madrid, , Spain

Site Status

Countries

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Spain

Central Contacts

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Isidro Fernández-López, PhD.

Role: CONTACT

34625598970

Facility Contacts

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Isidro Fernández-López, PhD.

Role: primary

+34625598970

Other Identifiers

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UComplutenseMadrid Fasisifer3

Identifier Type: -

Identifier Source: org_study_id

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