CFDB - Cystic Fibrosis DataBase

primary studies published RCT

The role of small intestinal bacterial overgrowth in cystic fibrosis: a randomized case-controlled clinical trial with rifaximin.

Study design (if review, criteria of inclusion for studies)

Randomized controlled trial

Participants

79 CF patients (median age 19.6 years; 9.2-36.9) with a positive Glucose Breath Test (GBT)

Interventions

Rifaximin 1200 mg for 14 days or no treatment.

Outcome measures

Questionnaire and GBT were repeated 1 month after the end of treatment or 45 days after the first negative GBT. BMI, SDS-BMI, serum albumin levels (p < 0.05)

Main results

Out of 79 patients, 25 were affected by SIBO (31.6%) with a significant correlation with lower BMI, SDS-BMI (p < 0.05) and serum albumin levels (p < 0.05), independently from pancreas insufficiency. Twenty-three patients took part in the randomized trial, 13 patients (56.5%) in rifaximin group and 10 patients (43.5%) in control group. Eradication rate of SIBO was 9/10 (90%) in rifaximin group and 2/6 (33.3%) in control group (p < 0.05). In the rifaximin group, gastrointestinal symptom improvement was observed in 4/5 patients aged 14 years (p < 0.05); in 2/6 patients in the control group.

Authors' conclusions

CF patients show a high prevalence of SIBO, related to a poorer nutritional status. Rifaximin therapy is well tolerated and the results are promising in terms of efficacy in eradicating small intestinal bacterial overgrowth in CF.

Keywords: Rifaximin; other anti-bacterial agents; Anti-Bacterial Agents; pharmacological_intervention;