Influence of Modern Colon Hydrotherapy on Intestinal Transit
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2024
CompletedFirst Posted
Study publicly available on registry
May 31, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedAugust 16, 2024
August 1, 2024
Same day
May 26, 2024
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intestinal transit
intestinal transit using radiopaque markers
7 days
Study Arms (2)
Modern Colon Hydrotherapy plus probiotic product intake
EXPERIMENTALColonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days.
Modern Colon Hydrotherapy plus placebo intake
ACTIVE COMPARATORColonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Complutense de Madrid
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isidro Fernández-López, PhD.
Universidad Complutense de Madrid
Central Study Contacts
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
May 26, 2024
First Posted
May 31, 2024
Study Start
September 1, 2024
Primary Completion
September 1, 2024
Study Completion
October 1, 2024
Last Updated
August 16, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share