Inflammatory Bowel Diseases Weight Changesobesity/IFXNCT07495800
Weight and BMI Patterns in Biological Based IBD Patients and Its Finacial Impact
An observational study of Inflammatory Bowel Diseases Weight Changes, run by Assiut University.
Trial summary
Primary Objective To determine the pattern of weight and body mass index (BMI) changes in biologic-treated patients with inflammatory bowel disease (IBD). Secondary Objectives To evaluate the correlation between BMI and biologic drug dosing. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases Weight Changes
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Patients underwent clinical, laboratory, endoscopic, and/or imaging evaluations as part of routine outpatient monitoring. Current medications and Serum IFX concentrations will offered for collection. * Laboratory investigations (Complete blood picture, Liver function tests, C-reactive protein and ESR, Fecal calprotectin). * The following variables were evaluated: age, sex, BMI [weight (kg)/height (m)²], smoking history, history of IBD-related surgeries, current and prior concomitant medications, disease duration, Montreal classification, and clinical activity indices for CD and UC. Clinical activity of CD was assessed using the Harvey-Bradshaw Index (HBI), with clinical remission defined as an HBI score ≤ 4 points. * Clinical activity of UC was assessed using the partial Mayo score, with clinical remission defined as a score ≤ 2 points
Who may be able to join
- Patients must have received infliximab (IFX) therapy for at least 14 weeks and completed the on-label induction regimen (5 mg/kg IV at weeks 0, 2, and 6), regardless of the dose at the time of blood collection (patients receiving optimized doses are eligible).
- Patients may be on IFX monotherapy or in combination with one of the following medications at the time of selection: aminosalicylates, antibiotics, prednisone, azathioprine, 6-mercaptopurine, or methotrexate.
Who cannot join
- Patients receiving IFX in combination with tacrolimus, cyclosporine, sirolimus, mycophenolate mofetil, another immunobiological agent, or tofacitinib.
- Patients with insufficient data in their electronic medical records.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Primary Objective To determine the pattern of weight and body mass index (BMI) changes in biologic-treated patients with inflammatory bowel disease (IBD).
Secondary Objectives To evaluate the correlation between BMI and biologic drug dosing. To estimate the direct financial burden of biologic therapy according to BMI categories.
To assess whether higher BMI is associated with increased treatment requirements.
Read the detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic conditions associated with reduced quality of life and impaired productivity. Due to recurrent disease activity and progressive structural damage, IBD imposes a significant burden on both public and private healthcare systems.
The use of advanced therapies for moderate to severe IBD has provided substantial benefits in recent decades, including reductions in hospitalization and surgery rates. Anti-Tumor Necrosis Factor-alpha (anti-TNF-α) agents typically constitute the first line of advanced therapy for both CD and UC. However, between 10% and 40% of patients may not respond to treatment (primary non-responders), and approximately 12% may lose response over time, particularly with infliximab (IFX).
Several mechanisms may contribute to IFX treatment failure. Immunogenicity, where antibodies form against the monoclonal antibody, is a primary factor. Other factors affecting IFX clearance include overweight and obesity. Drug clearance is influenced by the volume of distribution, which depends on patient weight. Additionally, excess adipose tissue can alter the pharmacokinetics of anti-TNF agents and exert endocrine and immunological effects through the release of adipocytokines, potentially contributing to the pathogenesis of inflammatory conditions. Therefore, excessive body weight may partly explain IFX therapy failure in some cases.
Obesity appears to negatively affect the response to immunosuppressants and anti-TNF agents. However, studies examining the relationship between obesity, anti-TNF response, and autoimmune diseases have reported inconsistent results. For example, an analysis of three randomized controlled trials of IFX in dermatology and rheumatology found no statistically significant differences in response rates across BMI groups. In contrast, a prospective cohort study in patients with rheumatoid arthritis reported that obese patients treated with IFX had lower clinical response rates. A systematic review and meta-analysis found that obesity was associated with a 60% higher likelihood of losing response to anti-TNF agents compared to non-obese patients with rheumatoid arthritis, ankylosing spondylitis, and psoriasis. However, this association has not been confirmed in patients with IBD.
To date, few studies have examined the influence of obesity or overweight on endoscopic remission in IBD. In a recent cohort study of IFX-treated patients, Singh et al. (2018) found no significant reduction in mucosal healing in obese patients after adjusting for covariates (CI: 0.12-2.35; p=0.31). Other recent studies have demonstrated that body composition parameters, such as subcutaneous adiposity index, visceral adiposity index, and skeletal muscle mass index, are independent factors correlated with active Crohn's disease, with visceral adiposity negatively impacting disease activity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of Weight Changes in Biologic-Treated IBD Patients
To assess the monthly changes in body weight (measured in kilograms using a calibrated digital scale) in patients with inflammatory bowel disease receiving biologic
Measured: Monthly assessment for 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 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 Diseases Weight ChangesStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495800
- Sponsor's protocol ID
- 4-2026-300824
- Acronym
- obesity/IFX
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight and BMI Patterns in Biological Based IBD Patients and Its Finacial Impact
- ClinicalTrials.gov ID
- NCT07495800
- Acronym / sponsor ID
- obesity/IFX / 4-2026-300824
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Mar 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.
Primary Objective To determine the pattern of weight and body mass index (BMI) changes in biologic-treated patients with inflammatory bowel disease (IBD).
Secondary Objectives To evaluate the correlation between BMI and biologic drug dosing. To estimate the direct financial burden of biologic therapy according to BMI categories.
To assess whether higher BMI is associated with increased treatment requirements.
Detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic conditions associated with reduced quality of life and impaired productivity. Due to recurrent disease activity and progressive structural damage, IBD imposes a significant burden on both public and private healthcare systems.
The use of advanced therapies for moderate to severe IBD has provided substantial benefits in recent decades, including reductions in hospitalization and surgery rates. Anti-Tumor Necrosis Factor-alpha (anti-TNF-α) agents typically constitute the first line of advanced therapy for both CD and UC. However, between 10% and 40% of patients may not respond to treatment (primary non-responders), and approximately 12% may lose response over time, particularly with infliximab (IFX).
Several mechanisms may contribute to IFX treatment failure. Immunogenicity, where antibodies form against the monoclonal antibody, is a primary factor. Other factors affecting IFX clearance include overweight and obesity. Drug clearance is influenced by the volume of distribution, which depends on patient weight. Additionally, excess adipose tissue can alter the pharmacokinetics of anti-TNF agents and exert endocrine and immunological effects through the release of adipocytokines, potentially contributing to the pathogenesis of inflammatory conditions. Therefore, excessive body weight may partly explain IFX therapy failure in some cases.
Obesity appears to negatively affect the response to immunosuppressants and anti-TNF agents. However, studies examining the relationship between obesity, anti-TNF response, and autoimmune diseases have reported inconsistent results. For example, an analysis of three randomized controlled trials of IFX in dermatology and rheumatology found no statistically significant differences in response rates across BMI groups. In contrast, a prospective cohort study in patients with rheumatoid arthritis reported that obese patients treated with IFX had lower clinical response rates. A systematic review and meta-analysis found that obesity was associated with a 60% higher likelihood of losing response to anti-TNF agents compared to non-obese patients with rheumatoid arthritis, ankylosing spondylitis, and psoriasis. However, this association has not been confirmed in patients with IBD.
To date, few studies have examined the influence of obesity or overweight on endoscopic remission in IBD. In a recent cohort study of IFX-treated patients, Singh et al. (2018) found no significant reduction in mucosal healing in obese patients after adjusting for covariates (CI: 0.12-2.35; p=0.31). Other recent studies have demonstrated that body composition parameters, such as subcutaneous adiposity index, visceral adiposity index, and skeletal muscle mass index, are independent factors correlated with active Crohn's disease, with visceral adiposity negatively impacting disease activity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Patients underwent clinical, laboratory, endoscopic, and/or imaging evaluations as part of routine outpatient monitoring. Current medications and Serum IFX concentrations will offered for collection. * Laboratory investigations (Complete blood picture, Liver function tests, C-reactive protein and ESR, Fecal calprotectin). * The following variables were evaluated: age, sex, BMI [weight (kg)/height (m)²], smoking history, history of IBD-related surgeries, current and prior concomitant medications, disease duration, Montreal classification, and clinical activity indices for CD and UC. Clinical activity of CD was assessed using the Harvey-Bradshaw Index (HBI), with clinical remission defined as an HBI score ≤ 4 points. * Clinical activity of UC was assessed using the partial Mayo score, with clinical remission defined as a score ≤ 2 points
Key inclusion criteria (2 listed)
- Patients must have received infliximab (IFX) therapy for at least 14 weeks and completed the on-label induction regimen (5 mg/kg IV at weeks 0, 2, and 6), regardless of the dose at the time of blood collection (patients receiving optimized doses are eligible).
- Patients may be on IFX monotherapy or in combination with one of the following medications at the time of selection: aminosalicylates, antibiotics, prednisone, azathioprine, 6-mercaptopurine, or methotrexate.
Key exclusion criteria (2 listed)
- Patients receiving IFX in combination with tacrolimus, cyclosporine, sirolimus, mycophenolate mofetil, another immunobiological agent, or tofacitinib.
- Patients with insufficient data in their electronic medical records.
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
Pattern of Weight Changes in Biologic-Treated IBD Patients
Time frame: Monthly assessment for 12 month
To assess the monthly changes in body weight (measured in kilograms using a calibrated digital scale) in patients with inflammatory bowel disease receiving biologic
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 30 Mar 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases Weight Changes, 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 2 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 30 Mar 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?
Contact Amira M. Abdelmawgod, MD, Assuit University (+201012760437, amiramohmad60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of Weight Changes in Biologic-Treated IBD Patients (time frame: Monthly assessment for 12 month). 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 30 Mar 2026.