Impact of Obesity on Response to Therapy and Clinical Outcom in Patients With Inflammatory Bowel Disease

NCT07343726 | Not Yet Recruiting DMC

• 1 other identifier: obesity IBS
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

• improvement rate of patients

  Clinical response to treatment

  3 months

Study Arms (2)

obese patients

obese patients who have BMI ≥ 30

non-obese patients

non-obese patients who have BMI \< 30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults (\>18 years) diagnosed with IBD

You may qualify if:

• Adults (\>18 years) diagnosed with IBD
• Currently receiving standard treatment (including biologics)

You may not qualify if:

• Patients with other causes of colitis (e.g. infectious, ischemic)
• Pregnant females
• Incomplete clinical or follow-up data

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01