Constipation - FunctionalNCT06438068
Influence of Modern Colon Hydrotherapy on Intestinal Transit
A study testing Modern Colon Hydrotherapy plus probiotic product intake in people with Constipation - Functional and Hydrotherapy, run by Universidad Complutense de Madrid at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Constipation - Functional, Hydrotherapy, Functional Colonic Diseases
- What is being tested?
- Modern Colon Hydrotherapy plus probiotic product intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad Complutense de Madrid
Madrid
Isidro Fernández-López, PhD., +34625598970, isidro.fernandez.lopez@gmail.com
David Granizo-Bermejo, Mr.
About this study
A randomised and controlled trial, in which the effect of Modern Colon Hydrotherapy is evaluated in the gastrointestinal transit of subjects with functional constipation
Read the 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.
- Being tested
- Modern Colon Hydrotherapy plus probiotic product intake
- Keywords
- constipation, internal hydrotherapy, Radiopaque Media, Functional Colonic Diseases
- Medical subject headings
- Colonic Diseases, Functional, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modern Colon Hydrotherapy plus probiotic product intakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Modern Colon Hydrotherapy plus probiotic product intake | Experimental | 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. Receives: Other: Modern Colon Hydrotherapy plus probiotic product intake |
| Modern Colon Hydrotherapy plus placebo intake | Active comparator | Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days. Receives: Other: Modern Colon Hydrotherapy plus probiotic product intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal transit
intestinal transit using radiopaque markers
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidro Fernández López, Universidad Complutense de Madrid
- Investigators
- Isidro Fernández-López, PhD., Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438068
- Sponsor's protocol ID
- UComplutenseMadrid Fasisifer3
- Status last verified
- Aug 2024
- First submitted
- 26 May 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Modern Colon Hydrotherapy on Intestinal Transit
- ClinicalTrials.gov ID
- NCT06438068
- Acronym / sponsor ID
- UComplutenseMadrid Fasisifer3
- Keywords
- constipation, internal hydrotherapy, Radiopaque Media, Functional Colonic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modern Colon Hydrotherapy plus probiotic product intake | Experimental | Other: Modern Colon Hydrotherapy plus probiotic product intakeColonic 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 comparator | Other: Modern Colon Hydrotherapy plus probiotic product intakeColonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modern Colon Hydrotherapy plus probiotic product intakeColonic 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. | Other | Modern Colon Hydrotherapy plus placebo intake, Modern Colon Hydrotherapy plus probiotic product intake |
Primary outcome
intestinal transit
Time frame: 7 days
intestinal transit using radiopaque markers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isidro Fernández-López, PhD. principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modern Colon Hydrotherapy plus probiotic product intake in people with Constipation - Functional and Hydrotherapy, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isidro Fernández-López, PhD. (34625598970, isidrofe@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal transit (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.