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NCT Number: NCT06438068

Influence of Modern Colon Hydrotherapy on Intestinal Transit

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, Spain

Location contact

David Granizo-Bermejo, Mr.

PRINCIPAL_INVESTIGATOR

Isidro Fernández-López, PhD.

CONTACT

[email protected]

+34625598970

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modern Colon Hydrotherapy plus probiotic product intake

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.

Primary outcomes

  1. intestinal transit

    Time frame: 7 days

    intestinal transit using radiopaque markers

Study contacts

Contact information is provided by the study sponsor or research team.

Isidro Fernández-López, PhD.

CONTACT

[email protected]

34625598970

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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