Functional Gastrointestinal DisordersNCT06017856
Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children
An observational study of Functional Gastrointestinal Disorders and Obesity, Childhood, run by Meir Medical Center at 1 site in Israel.
Trial summary
A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders, Obesity, Childhood
- What is being tested?
- Life style intervention program
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Feb 2024to Nov 2024
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: obese and overweight subjects patricipating in the life style modification program as well as healhy controls of normal weight
Who may be able to join
- obese / overweight children participating in the life style modification program at the child sport and health center
Who cannot join
- other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 4464402
Eyal Zifman, MD, +97297471596, eyalzi@clalit.org.il
About this study
Official title: The Impact of Physical Exercise and Nutrition on Functional Gastrointestinal Disorders in Obese Children
A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.
Read the detailed description
The investigators intend to conduct a prospective observational case-control study of overweight and obese children, aged 6-18 years, followed in the child health and sport center at Meir medical center, Kfar-Saba, Israel.
Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be offered to participate. Healthy subjects with normal BMI percentile from other pediatric outpatient clinics as well as relatives and friends of physicians from the pediatric division will be enrolled and serve as the control group.
Study visits will be at enrollment and after 3 and 6 months of participation in the intervention program. During the visits the investigators will collect anthropometric measurements (height, weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y) will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. The investigators will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program.
The investigators will then compare between subjects who succeeded to those who failed in losing at least 5% of their initial body weight as well as to healthy controls with normal BMI percentile.
- Being tested
- Life style intervention program
- Keywords
- obese, overweight, abdominal pain, diarrhea
- Medical subject headings
- Gastrointestinal Diseases, Pediatric Obesity, Obesity, Overweight, Abdominal Pain, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life style intervention programOther
Life style intervention program for the obese/overweight subjects conducted regardless of this study at the child sport and health center at Meir medical center
| Study group | Role | What they receive |
|---|---|---|
| obese and overweight | Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, participating the in life-style intervention program in the child sport center at Meir medical center Receives: Other: Life style intervention program | |
| normal weight | normal weight subjects defined as body mass index (BMI) percentile <85%, with no other chronic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of functional gastrointestinal disorder
The number of participants with a diagnosis of functional gastrointestinal disorder according to the Rome IV criteria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start6 Feb 2024
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eyal zifman, Meir Medical Center
- Investigators
- Eyal Zifman, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017856
- Sponsor's protocol ID
- MMC-22-0199
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2023
- Last updated
- 9 Feb 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Exercise and Nutrition on Functional Gastrointestinal Disorders in Obese Children
- ClinicalTrials.gov ID
- NCT06017856
- Acronym / sponsor ID
- MMC-22-0199
- Keywords
- obese, overweight, abdominal pain, diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 30 Aug 2023 (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 prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.
Detailed description
The investigators intend to conduct a prospective observational case-control study of overweight and obese children, aged 6-18 years, followed in the child health and sport center at Meir medical center, Kfar-Saba, Israel.
Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be offered to participate. Healthy subjects with normal BMI percentile from other pediatric outpatient clinics as well as relatives and friends of physicians from the pediatric division will be enrolled and serve as the control group.
Study visits will be at enrollment and after 3 and 6 months of participation in the intervention program. During the visits the investigators will collect anthropometric measurements (height, weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y) will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. The investigators will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program.
The investigators will then compare between subjects who succeeded to those who failed in losing at least 5% of their initial body weight as well as to healthy controls with normal BMI percentile.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese and overweight | – | Other: Life style intervention programOverweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, participating the in life-style intervention program in the child sport center at Meir medical center |
| normal weight | – | –normal weight subjects defined as body mass index (BMI) percentile <85%, with no other chronic conditions |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- obese and overweight subjects patricipating in the life style modification program as well as healhy controls of normal weight
Key inclusion criteria (1 listed)
- obese / overweight children participating in the life style modification program at the child sport and health center
Key exclusion criteria (1 listed)
- other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)
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 |
|---|---|---|
| Life style intervention programLife style intervention program for the obese/overweight subjects conducted regardless of this study at the child sport and health center at Meir medical center | Other | obese and overweight |
Primary outcome
Diagnosis of functional gastrointestinal disorder
Time frame: 6 months
The number of participants with a diagnosis of functional gastrointestinal disorder according to the Rome IV criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Functional Gastrointestinal Disorders
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
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.
Eyal Zifman, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders and Obesity, Childhood, run by Meir Medical Center at 1 site in Israel.
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 1 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 9 Feb 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 Israel. 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 Eyal Zifman, MD (+97297471596, eyalzi@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of functional gastrointestinal disorder (time frame: 6 months). 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 9 Feb 2024.