## Protocol Section
### Identification Module
**NCT ID:** NCT06438068

**Brief Title:** Influence of Modern Colon Hydrotherapy on Intestinal Transit

**Official Title:** Influence of Modern Colon Hydrotherapy on Intestinal Transit

#### Organization Study ID Info
**ID:** UComplutenseMadrid Fasisifer3
#### Organization
**Class:** OTHER
**Full Name:** Universidad Complutense de Madrid
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-26

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad Complutense de Madrid

#### Responsible Party

**Investigator Affiliation:** Universidad Complutense de Madrid

**Investigator Full Name:** Isidro Fernández López

**Investigator Title:** PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

**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.

### Conditions Module

**Conditions:**

- Constipation - Functional

- Hydrotherapy

- Functional Colonic Diseases

**Keywords:**

- constipation

- internal hydrotherapy

- Radiopaque Media

- Functional Colonic Diseases

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Modern Colon Hydrotherapy plus probiotic product intake

**Label:** Modern Colon Hydrotherapy plus probiotic product intake

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Modern Colon Hydrotherapy plus probiotic product intake

**Label:** Modern Colon Hydrotherapy plus placebo intake

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Modern Colon Hydrotherapy plus placebo intake

- Modern Colon Hydrotherapy plus probiotic product intake

**Description:** 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.

**Name:** Modern Colon Hydrotherapy plus probiotic product intake

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** intestinal transit using radiopaque markers

**Measure:** intestinal transit

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 60 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** isidrofe@ucm.es

**Name:** Isidro Fernández-López, PhD.

**Phone:** 34625598970

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Email:** isidro.fernandez.lopez@gmail.com

- **Name:** Isidro Fernández-López, PhD.

- **Phone:** +34625598970

- **Role:** CONTACT

***Contact 2:***

- **Name:** David Granizo-Bermejo, Mr.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Universidad Complutense de Madrid

#### Overall Officials

**Official 1:**

**Affiliation:** Universidad Complutense de Madrid

**Name:** Isidro Fernández-López, PhD.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6336

- Name: Colonic Diseases

- Relevance: HIGH

- As Found: Colonic Diseases

- ID: M6337

- Name: Colonic Diseases, Functional

- Relevance: HIGH

- As Found: Functional Colonic Diseases

- ID: M6472

- Name: Constipation

- Relevance: HIGH

- As Found: Constipation

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003108

- Term: Colonic Diseases

- ID: D000003109

- Term: Colonic Diseases, Functional

- ID: D000003248

- Term: Constipation

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
