Evaluating the Efficacy of Probiotics on Disease Progression, Quality of Life, and Nutritional Status Among Patients with Crohn's Disease: A Multicenter, Randomized, Single-Blinded Controlled Trial

Abstract

Background: There is growing interest in the role of gut microbiota in the pathophysiology of inflammatory bowel diseases (IBDs), including Crohn's disease (CD). Probiotics have been proposed as a potential adjunct therapy for these conditions by altering the intestinal environment, although studies on their effectiveness have yielded mixed results.

Aim: This study aims to evaluate the short-term (2 months) effects of a dietary supplement containing Lactobacilli, Bifidobacteria, and Lactococcus bacillus on disease progression, remission, quality of life, and nutritional intake in Lebanese patients with CD.

Method: A multicenter, randomized, single-blind controlled trial was conducted in 2 medical centers in Beirut from 1 April 2024 to 1 August 2024. Recruitment, prescreening, screening, enrollment, and protocol implementation were carried out at both centers. Data were collected from 21 patients with CD, who were randomly assigned to the control group (n = 10) and the intervention group (n = 11). At baseline and after two months, participants underwent clinical assessments, WHOQOL-BREF evaluation, and 24 h dietary recalls. Follow-up visits included surveys on disease progression, quality of life, adherence, and adverse events, along with repeat body composition and anthropometric measurements.

Results: Probiotic supplementation over two months did not significantly alter symptoms, flares, or hospitalizations outcomes between the control and intervention groups. However, the intervention group experienced notable increases in body weight (p = 0.01), BMI (p = 0.01), body fat mass (p = 0.04), and arm muscle circumference (p = 0.01). Nutrient intake patterns differed, with the intervention group showing increased consumption of calcium, riboflavin, and folate compared to controls (p = 0.01, p = 0.04, p = 0.013, respectively). Probiotic supplementation led to significant within-group increases in dietary fiber (p = 0.01), total sugar (p = 0.02), and caffeine (p = 0.01) among the intervention participants. Adverse effects in the intervention group were mild, including nausea (18.2%) and abdominal discomfort (9.1%). QOL improved significantly in the intervention group, particularly in physical (p = 0.03), psychological (p = 0.04), and environmental domains (p = 0.003), while the control group exhibited improvements only in psychological health.

Conclusions: Overall, the findings suggest that probiotics can enhance body composition, nutrient intake, and certain aspects of QOL among CD patients, despite minimal impact on disease symptoms or dietary patterns.

Keywords: Bifidobacteria; Crohn’s disease; Lactobacillus; Lebanon; probiotics; randomized clinical trial.