Objectives: To evaluate the effect of a probiotic supplement containing two genera and five species of bacteria versus placebo on the quality of life (QoL) in female university students with intestinal constipation (IC). Design: A randomized, double-blind placebo-controlled study was conducted on female university students in a single study center. Settings/Location: Two phases of interventions were carried out, the pilot and main study. All participants were female students of Federal University of Mato Grosso, Brazil. Subjects: Female students whose ages ranged from 20 to 40 years and self-reported to be suffering from IC based on a questionnaire containing Rome III criteria were included. Interventions: Interventions occurred during a period of 30 days in the pilot phase (n = 32) and 15 days in the main study phase (n = 63). The subjects were numbered and randomly divided into experimental probiotic and placebo control groups. Therefore, neither the participants nor the researchers were aware of the allocations of the treatment groups. Outcome measures: The sociodemographic, Rome III, Patient Assessment of Constipation Quality of Life (PAC-QoL) and International Physical Activity questionnaires, and anthropometric measures were utilized. The relative risk (RR) treatment effect, absolute risk reduction (ARR), RR reduction, number needed to treat (NNT), and odds ratio were calculated. Results: Improvement in the QoL (ARR = 14% and p < 0.01) and satisfaction (ARR = 44% and p < 0.01) according to the PAC-QoL questionnaire was observed in the experimental group compared with the control group. For probiotic supplementation, an NNT = 7 was obtained. This implies that for every seven constipated women treated, a worsening in the QoL is prevented in one. An NNT = 1 was obtained concerning satisfaction in the same group of women with respect to the treatment. No clinically significant observations related to the safety of the product were reported. The authors did not detect the effect of exercise intensity on the QoL of participants. Conclusion: The probiotic supplementation had a positive impact on the QoL of constipated female university students.
RCT Entities:
Objectives: To evaluate the effect of a probiotic supplement containing two genera and five species of bacteria versus placebo on the quality of life (QoL) in female university students with intestinal constipation (IC). Design: A randomized, double-blind placebo-controlled study was conducted on female university students in a single study center. Settings/Location: Two phases of interventions were carried out, the pilot and main study. All participants were female students of Federal University of Mato Grosso, Brazil. Subjects: Female students whose ages ranged from 20 to 40 years and self-reported to be suffering from IC based on a questionnaire containing Rome III criteria were included. Interventions: Interventions occurred during a period of 30 days in the pilot phase (n = 32) and 15 days in the main study phase (n = 63). The subjects were numbered and randomly divided into experimental probiotic and placebo control groups. Therefore, neither the participants nor the researchers were aware of the allocations of the treatment groups. Outcome measures: The sociodemographic, Rome III, Patient Assessment of Constipation Quality of Life (PAC-QoL) and International Physical Activity questionnaires, and anthropometric measures were utilized. The relative risk (RR) treatment effect, absolute risk reduction (ARR), RR reduction, number needed to treat (NNT), and odds ratio were calculated. Results: Improvement in the QoL (ARR = 14% and p < 0.01) and satisfaction (ARR = 44% and p < 0.01) according to the PAC-QoL questionnaire was observed in the experimental group compared with the control group. For probiotic supplementation, an NNT = 7 was obtained. This implies that for every seven constipatedwomen treated, a worsening in the QoL is prevented in one. An NNT = 1 was obtained concerning satisfaction in the same group of women with respect to the treatment. No clinically significant observations related to the safety of the product were reported. The authors did not detect the effect of exercise intensity on the QoL of participants. Conclusion: The probiotic supplementation had a positive impact on the QoL of constipated female university students.
Entities:
Keywords:
exercise; intestinal constipation; probiotics; quality of life