Inflammatory Bowel Disease (IBD)NCT07343726
Impact of Obesity on Response to Therapy and Clinical Outcom in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD), run by Assiut University.
Trial summary
Inflammatory Bowel Disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), is a group of chronic relapsing inflammatory disorders of the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (>18 years) diagnosed with IBD
Who may be able to join
- Adults (>18 years) diagnosed with IBD
- Currently receiving standard treatment (including biologics)
Who cannot join
- Patients with other causes of colitis (e.g. infectious, ischemic)
- Pregnant females
- Incomplete clinical or follow-up data
About this study
Inflammatory Bowel Disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), is a group of chronic relapsing inflammatory disorders of the gastrointestinal tract. Its pathogenesis is multifactorial, involving genetic predisposition, environmental triggers, immune dysregulation, and microbial imbalance. IBD has significant morbidity and a major impact on quality of life, with varied clinical presentations and disease behavior (1,2).
Obesity, defined as excessive body fat accumulation, is increasingly prevalent worldwide. It is now recognized as a state of chronic low-grade systemic inflammation due to adipose tissue secreting pro-inflammatory cytokines such as TNF-α and IL-6 (3,4). These cytokines may interact with pathways relevant to IBD, particularly in altering the immune response and intestinal inflammation (5).
Read more
recent studies suggest that obese IBD patients may experience a different disease phenotype, increased complications, and lower response rates to certain biologics, especially anti-TNF agents (6,7). In addition, obesity can alter drug pharmacokinetics, leading to reduced drug efficacy (8,9).
Despite increasing evidence of this association, there is limited local data evaluating the prevalence of obesity in IBD and its impact on treatment response and disease outcome (10,11). Understanding this link could help improve personalized treatment approaches and predict treatment outcomes in IBD patients (12,13).
Obesity has emerged as a modifiable factor that may influence the clinical response to therapy in patients with inflammatory bowel disease (IBD). Recent studies have shown that higher body mass index (BMI) is associated with reduced steroid-free clinical remission rates in patients treated with advanced biologic and small molecule therapies. The inflammatory nature of adipose tissue, altered pharmacokinetics, and increased drug clearance in obese individuals might explain the suboptimal therapeutic outcomes observed in this population
- Conditions
- Inflammatory Bowel Disease (IBD)
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obese patients | obese patients who have BMI ≥ 30 | |
| non-obese patients | non-obese patients who have BMI < 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement rate of patients
Clinical response to treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Mahmoud Abdelmohsen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343726
- Sponsor's protocol ID
- obesity IBS
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on Response to Therapy and Clinical Outcom in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07343726
- Acronym / sponsor ID
- obesity IBS
- Conditions
- Inflammatory Bowel Disease (IBD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Jan 2026 (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.
Inflammatory Bowel Disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), is a group of chronic relapsing inflammatory disorders of the gastrointestinal tract. Its pathogenesis is multifactorial, involving genetic predisposition, environmental triggers, immune dysregulation, and microbial imbalance. IBD has significant morbidity and a major impact on quality of life, with varied clinical presentations and disease behavior (1,2).
Obesity, defined as excessive body fat accumulation, is increasingly prevalent worldwide. It is now recognized as a state of chronic low-grade systemic inflammation due to adipose tissue secreting pro-inflammatory cytokines such as TNF-α and IL-6 (3,4). These cytokines may interact with pathways relevant to IBD, particularly in altering the immune response and intestinal inflammation (5).
recent studies suggest that obese IBD patients may experience a different disease phenotype, increased complications, and lower response rates to certain biologics, especially anti-TNF agents (6,7). In addition, obesity can alter drug pharmacokinetics, leading to reduced drug efficacy (8,9).
Despite increasing evidence of this association, there is limited local data evaluating the prevalence of obesity in IBD and its impact on treatment response and disease outcome (10,11). Understanding this link could help improve personalized treatment approaches and predict treatment outcomes in IBD patients (12,13).
Obesity has emerged as a modifiable factor that may influence the clinical response to therapy in patients with inflammatory bowel disease (IBD). Recent studies have shown that higher body mass index (BMI) is associated with reduced steroid-free clinical remission rates in patients treated with advanced biologic and small molecule therapies. The inflammatory nature of adipose tissue, altered pharmacokinetics, and increased drug clearance in obese individuals might explain the suboptimal therapeutic outcomes observed in this population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese patients | – | –obese patients who have BMI ≥ 30 |
| non-obese patients | – | –non-obese patients who have BMI < 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (>18 years) diagnosed with IBD
Key inclusion criteria (2 listed)
- Adults (>18 years) diagnosed with IBD
- Currently receiving standard treatment (including biologics)
Key exclusion criteria (3 listed)
- Patients with other causes of colitis (e.g. infectious, ischemic)
- Pregnant females
- Incomplete clinical or follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
improvement rate of patients
Time frame: 3 months
Clinical response to treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD), run by Assiut University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
improvement rate of patients (time frame: 3 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 15 Jan 2026.