Effect of dietary therapy with a probiotic mixture (Ecologic BARRIER) on the gut microbiome and fatigue symptoms in patients with quiescent inflammatory bowel disease - A clinical trial - Probiotic therapy in Inflammatory bowel disease

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•* Age 18-75 years
•* Confirmed CD or UC or IBD-unspecified diagnosed according to standard criteria
•* Quiescent disease defined as HBI * 4 for CD and SCCAI * 2 for UC
•* Persistent ongoing fatigue symptoms, defined as FACIT-F < 43
•* Normal fecal calprotectin (< 250ug/g) and C-reactive protein (< 8mg/L) within 12 months of screening
•* Endoscopic or radiologic remission within 12 months of screening

•* Patients with clinical or endoscopically active inflammatory bowel disease
•* Significant non-IBD comorbidity contributing to the fatigue (such as active cancer).
•* Untreated severe depression or anxiety
•* Known sleep disorders without adequate treatment,
•* Concurrent use of narcotics or long-term oral antibiotic therapy
•* Severe vitamin D deficiency (< 10 ng/mL)
•* J-pouch or a stoma
•* Ongoing use of other non-study probiotics
•* Women who are pregnant or lactating

发起方