Constipation - FunctionalNCT06925802
Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults
A study testing visceral manipulation in people with Constipation - Functional, run by MTI University at 1 site in Egypt.
Trial summary
Functional constipation in obese adults is a prevalent gastrointestinal issue characterized by infrequent bowel movements, difficulty during defecation, or a sensation of incomplete evacuation. Obesity is a significant risk factor for functional constipation due to several physiological and lifestyle-related factors. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- visceral manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2025to 25 Apr 2025
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed with functional constipation according to Rome IV criteria
- Body mass index (BMI) ≥ 30 kg/m²
- Ability to provide informed consent
Who cannot join
- patients with organic gastrointestinal diseases, Pregnancy or lactation
- Participation in another clinical trial within the last 30 days, Endocrine and metabolic disorders (eg, hypothyroidism, hypercalcemia, diabetes mellitus, diabetes insipidus)
- Neurologic and psychiatric disorders (spina bifida, cerebral palsy, anorexia nervosa, known autism spectrum disorders)
- Secondary constipation to drug consumption, History of abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults: Randomized Controlled Clinical Trial
Functional constipation in obese adults is a prevalent gastrointestinal issue characterized by infrequent bowel movements, difficulty during defecation, or a sensation of incomplete evacuation. Obesity is a significant risk factor for functional constipation due to several physiological and lifestyle-related factors. Excess body weight, particularly in the abdominal region, may exert pressure on the colon, leading to disrupted bowel function. Additionally, dietary habits common among obese individuals, such as low fiber intake and inadequate hydration, can worsen constipation. Sedentary lifestyles further contribute to reduced gastrointestinal motility. Addressing functional constipation in obese adults requires a multifaceted approach, including dietary modifications to increase fiber and fluid intake, regular physical activity, and, in some cases, medical interventions to alleviate symptoms and improve quality of life.
Read the detailed description
Visceral manipulation is a gentle manual therapy that focuses on the internal organs, particularly those within the gastrointestinal tract, to enhance their function and alleviate symptoms associated with various disorders. Practitioners of visceral manipulation use their hands to apply specific, subtle forces to the affected areas, aiming to improve the mobility and motility of the organs. This technique is based on the premise that the body's organs are interconnected by fascia and ligaments, and any restriction or imbalance in these connections can lead to dysfunction and disease. By restoring the natural movement of these organs, visceral manipulation is believed to improve blood circulation, enhance digestive function, and reduce pain and discomfort associated with gastrointestinal disorders.
- Conditions
- Constipation - Functional
- Being tested
- visceral manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visceral manipulationOther
Also called standard care only
The procedure begins with the patient lying in a comfortable supine position to ensure relaxation and access to the abdominal region. Gentle palpation is used to assess tissue mobility and identify any restrictions or tension points. The practitioner applies light, rhythmic pressure to the gastroduodenal junction to stimulate movement and improve coordination between the stomach and duodenum. Attention is then given to the sphincter of Oddi, where soft, sustained pressure is employed to facilitate the release of bile and pancreatic juices, aiding digestive processes. Moving to the duodenojejunal flexure, the therapist uses gentle stretching and mobilization techniques to alleviate any obstructions, promoting smoother passage of intestinal contents. Finally, the sigmoid colon is manipulated with circular and oscillatory pressures to enhance peristalsis and relieve constipation.
| Study group | Role | What they receive |
|---|---|---|
| osteopathic visceral manipulation | Experimental | Group A received osteopathic visceral manipulation with standard care Receives: Other: visceral manipulation |
| control | No intervention | Group B received standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency
Patients were asked to describe the consistency of their stools during the previous month, choosing between the terms "hard or very hard," "not too hard, not too soft (normal)," "soft or very soft," "mucous, with undigested food," and "liquid," they also had the opportunity to answer that the stools were "variable" in consistency. In addition, patients were asked to choose the BSS stool type that best represented their stools on a picture chart
Measured: at baseline and at three weeks
Defecation Pain
Clearly explain to the patient the purpose of assessing their defecation pain using Arabic version of Visual Analogue Scale (VAS) form: A horizontal or vertical line, typically 10 centimeters in length, anchored by two descriptors at each end representing "no pain" and "worst possible pain."
Measured: at baseline and at three weeks
Secondary outcomes (2)
Defecation frequency
Utilize a standardized stool diary where participants record each defecation event, including the date
Measured: at baseline and at three weeks
Dose of oral laxative
dose of oral laxative and time. Ensure the diary is easy to use to promote accurate self-reporting. Supplement diary entries with qualitative interviews to understand lifestyle, dietary habits, and stress levels, which may influence bowel movement
Measured: at baseline and at three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start25 Mar 2025
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
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.
- 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
- Model description
- RCT
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925802
- Sponsor's protocol ID
- IRB # 22 /3 / 2024-2025
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 29 Apr 2025
- 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 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06925802
- Acronym / sponsor ID
- IRB # 22 /3 / 2024-2025
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 13 Apr 2025 (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.
Functional constipation in obese adults is a prevalent gastrointestinal issue characterized by infrequent bowel movements, difficulty during defecation, or a sensation of incomplete evacuation. Obesity is a significant risk factor for functional constipation due to several physiological and lifestyle-related factors. Excess body weight, particularly in the abdominal region, may exert pressure on the colon, leading to disrupted bowel function. Additionally, dietary habits common among obese individuals, such as low fiber intake and inadequate hydration, can worsen constipation. Sedentary lifestyles further contribute to reduced gastrointestinal motility. Addressing functional constipation in obese adults requires a multifaceted approach, including dietary modifications to increase fiber and fluid intake, regular physical activity, and, in some cases, medical interventions to alleviate symptoms and improve quality of life.
Detailed description
Visceral manipulation is a gentle manual therapy that focuses on the internal organs, particularly those within the gastrointestinal tract, to enhance their function and alleviate symptoms associated with various disorders. Practitioners of visceral manipulation use their hands to apply specific, subtle forces to the affected areas, aiming to improve the mobility and motility of the organs. This technique is based on the premise that the body's organs are interconnected by fascia and ligaments, and any restriction or imbalance in these connections can lead to dysfunction and disease. By restoring the natural movement of these organs, visceral manipulation is believed to improve blood circulation, enhance digestive function, and reduce pain and discomfort associated with gastrointestinal disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| osteopathic visceral manipulation | Experimental | Other: visceral manipulationGroup A received osteopathic visceral manipulation with standard care |
| control | No intervention | –Group B received standard care only |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients diagnosed with functional constipation according to Rome IV criteria
- Body mass index (BMI) ≥ 30 kg/m²
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- patients with organic gastrointestinal diseases, Pregnancy or lactation
- Participation in another clinical trial within the last 30 days, Endocrine and metabolic disorders (eg, hypothyroidism, hypercalcemia, diabetes mellitus, diabetes insipidus)
- Neurologic and psychiatric disorders (spina bifida, cerebral palsy, anorexia nervosa, known autism spectrum disorders)
- Secondary constipation to drug consumption, History of abdominal surgery
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 |
|---|---|---|
| visceral manipulationAlso: standard care onlyThe procedure begins with the patient lying in a comfortable supine position to ensure relaxation and access to the abdominal region. Gentle palpation is used to assess tissue mobility and identify any restrictions or tension points. The practitioner applies light, rhythmic pressure to the gastroduodenal junction to stimulate movement and improve coordination between the stomach and duodenum. Attention is then given to the sphincter of Oddi, where soft, sustained pressure is employed to facilitate the release of bile and pancreatic juices, aiding digestive processes. Moving to the duodenojejunal flexure, the therapist uses gentle stretching and mobilization techniques to alleviate any obstructions, promoting smoother passage of intestinal contents. Finally, the sigmoid colon is manipulated with circular and oscillatory pressures to enhance peristalsis and relieve constipation. | Other | osteopathic visceral manipulation |
Primary outcome
Stool consistency
Time frame: at baseline and at three weeks
Patients were asked to describe the consistency of their stools during the previous month, choosing between the terms "hard or very hard," "not too hard, not too soft (normal)," "soft or very soft," "mucous, with undigested food," and "liquid," they also had the opportunity to answer that the stools were "variable" in consistency. In addition, patients were asked to choose the BSS stool type that best represented their stools on a picture chart
Defecation Pain
Time frame: at baseline and at three weeks
Clearly explain to the patient the purpose of assessing their defecation pain using Arabic version of Visual Analogue Scale (VAS) form: A horizontal or vertical line, typically 10 centimeters in length, anchored by two descriptors at each end representing "no pain" and "worst possible pain."
2 secondary outcomes
Defecation frequency
Time frame: at baseline and at three weeks
Dose of oral laxative
Time frame: at baseline and at three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visceral manipulation in people with Constipation - Functional, run by MTI University at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 29 Apr 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool consistency (time frame: at baseline and at three weeks). The study lists 2 primary outcomes in all. 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 29 Apr 2025.