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Probiotics prevent hepatic encephalopathy in patients with cirrhosis: a randomized controlled trial.
Clin Gastroenterol Hepatol 2014; 12(6):1003-8.e1CG

Abstract

BACKGROUND & AIMS

Hepatic encephalopathy (HE) is associated with a poor prognosis in patients with advanced liver disease. Probiotics alter the intestinal microbiota with non-urease-producing organisms that reduce production of ammonia. We investigated the efficacy of probiotics for the primary prophylaxis of HE.

METHODS

We conducted a prospective trial at a tertiary care referral institute in New Delhi, India, from January 2012 through March 2013, of patients with cirrhosis without overt HE (age, 48.6 ± 11.1 y; 96 men and 64 women); 25 were Child-Turcotte-Pugh (CTP) class A, 51 were CTP class B, and 84 were CTP class C. Subjects were assigned randomly to groups given probiotics (1 × 10(8) colony-forming units, 3 times daily; n = 86, 42 with minimal HE) or no test article (control, n = 74; 33 with minimal HE). All subjects underwent psychometric analyses, critical flicker fusion (CFF) threshold assessments, glucose hydrogen breath tests to identify small intestinal bacterial overgrowth (SIBO), and lactulose hydrogen breath tests to measure orocecal transit time (OCTT). The primary end point was the development of overt HE.

RESULTS

At baseline, subjects in each group had comparable CTP score, model for end-stage liver disease scores, CFF assessments, psychometric hepatic encephalopathy scores, and OCTT. After a mean follow-up period of 38.6 ± 8.80 weeks for patients given probiotics and 40.3 ± 9.8 weeks for controls, 6 patients given probiotics and 7 controls died (P = .81). Three months of probiotic administration significantly reduced levels of arterial ammonia, SIBO, and OCTT; increased psychometric hepatic encephalopathy scores; and increased CFF thresholds, compared with baseline. Seven subjects in the probiotic group and 14 controls developed overt HE (P < .05; hazard ratio for controls vs probiotic group, 2.1; 95% confidence interval, 1.31-6.53). Psychometric hepatic encephalopathy scores, CTP scores, and SIBO correlated with the development of overt HE.

CONCLUSIONS

In a prospective, randomized controlled trial, probiotics were found to be effective in preventing HE in patients with cirrhosis. Trial registration No: CTRI/2012/07/002807.

Authors+Show Affiliations

Department of Gastroenterology, G B Pant Hospital, New Delhi, India.Department of Gastroenterology, G B Pant Hospital, New Delhi, India. Electronic address: drbcsharma@hotmail.com.Department of Gastroenterology, G B Pant Hospital, New Delhi, India.Department of Gastroenterology, G B Pant Hospital, New Delhi, India.Department of Gastroenterology, G B Pant Hospital, New Delhi, India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24246768

Citation

Lunia, Manish Kumar, et al. "Probiotics Prevent Hepatic Encephalopathy in Patients With Cirrhosis: a Randomized Controlled Trial." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 12, no. 6, 2014, pp. 1003-8.e1.
Lunia MK, Sharma BC, Sharma P, et al. Probiotics prevent hepatic encephalopathy in patients with cirrhosis: a randomized controlled trial. Clin Gastroenterol Hepatol. 2014;12(6):1003-8.e1.
Lunia, M. K., Sharma, B. C., Sharma, P., Sachdeva, S., & Srivastava, S. (2014). Probiotics prevent hepatic encephalopathy in patients with cirrhosis: a randomized controlled trial. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 12(6), pp. 1003-8.e1. doi:10.1016/j.cgh.2013.11.006.
Lunia MK, et al. Probiotics Prevent Hepatic Encephalopathy in Patients With Cirrhosis: a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2014;12(6):1003-8.e1. PubMed PMID: 24246768.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Probiotics prevent hepatic encephalopathy in patients with cirrhosis: a randomized controlled trial. AU - Lunia,Manish Kumar, AU - Sharma,Barjesh Chander, AU - Sharma,Praveen, AU - Sachdeva,Sanjeev, AU - Srivastava,Siddharth, Y1 - 2013/11/15/ PY - 2013/06/02/received PY - 2013/10/10/revised PY - 2013/11/06/accepted PY - 2013/11/20/entrez PY - 2013/11/20/pubmed PY - 2015/1/8/medline KW - Clinical Trial KW - Cognitive and Motor Function KW - MHE KW - Therapy KW - Treatment SP - 1003 EP - 8.e1 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin. Gastroenterol. Hepatol. VL - 12 IS - 6 N2 - BACKGROUND & AIMS: Hepatic encephalopathy (HE) is associated with a poor prognosis in patients with advanced liver disease. Probiotics alter the intestinal microbiota with non-urease-producing organisms that reduce production of ammonia. We investigated the efficacy of probiotics for the primary prophylaxis of HE. METHODS: We conducted a prospective trial at a tertiary care referral institute in New Delhi, India, from January 2012 through March 2013, of patients with cirrhosis without overt HE (age, 48.6 ± 11.1 y; 96 men and 64 women); 25 were Child-Turcotte-Pugh (CTP) class A, 51 were CTP class B, and 84 were CTP class C. Subjects were assigned randomly to groups given probiotics (1 × 10(8) colony-forming units, 3 times daily; n = 86, 42 with minimal HE) or no test article (control, n = 74; 33 with minimal HE). All subjects underwent psychometric analyses, critical flicker fusion (CFF) threshold assessments, glucose hydrogen breath tests to identify small intestinal bacterial overgrowth (SIBO), and lactulose hydrogen breath tests to measure orocecal transit time (OCTT). The primary end point was the development of overt HE. RESULTS: At baseline, subjects in each group had comparable CTP score, model for end-stage liver disease scores, CFF assessments, psychometric hepatic encephalopathy scores, and OCTT. After a mean follow-up period of 38.6 ± 8.80 weeks for patients given probiotics and 40.3 ± 9.8 weeks for controls, 6 patients given probiotics and 7 controls died (P = .81). Three months of probiotic administration significantly reduced levels of arterial ammonia, SIBO, and OCTT; increased psychometric hepatic encephalopathy scores; and increased CFF thresholds, compared with baseline. Seven subjects in the probiotic group and 14 controls developed overt HE (P < .05; hazard ratio for controls vs probiotic group, 2.1; 95% confidence interval, 1.31-6.53). Psychometric hepatic encephalopathy scores, CTP scores, and SIBO correlated with the development of overt HE. CONCLUSIONS: In a prospective, randomized controlled trial, probiotics were found to be effective in preventing HE in patients with cirrhosis. Trial registration No: CTRI/2012/07/002807. SN - 1542-7714 UR - https://www.unboundmedicine.com/medline/citation/24246768/Probiotics_prevent_hepatic_encephalopathy_in_patients_with_cirrhosis:_a_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(13)01743-6 DB - PRIME DP - Unbound Medicine ER -