A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome

Abstract

BackgroundIrritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations.MethodsA multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS – Constipation or IBS – Mixed profile). Set in 13 general practices within central England. Individuals meeting the ROME III criteria for IBS, aged 18–65 completed a pre-study diary. Eligible individuals were randomized to consume dairy ‘yoghurt’ products which either did or did not contain active probiotics twice daily and to complete a daily diary. Primary outcome was subjective global assessment of symptom relief at week 4. Other outcomes comprised, IBS symptom scores, pain, bloating and flatulence levels, stool frequency, stool consistency, ease of bowel movement and quality of life.Results179 were randomized (91 active, 88 placebo). 76 (43 active, 33 placebo) completed the study. No significant between group differences existed at 4 weeks (57% active vs 53% placebo, reported adequate relief (p = 0.71)). By week 8, 46% active vs 68% placebo reported adequate relief (p = 0.03). This was sustained at week 12.ConclusionsSignificant improvements were reported for most outcomes in all trial participants but improvement did not differ by group. This trial does not provide evidence for effectiveness of a probiotic in IBS, in variance with a body of published literature and review conclusions. Differential drop out may however cloud interpretation of data.UK Trial registration:ISRCTN78863629

Probiotic Therapy of the Irritable Bowel Syndrome: Why Is the Evidence Still Poor and What Can Be Done About It?

“…One study included patients with functional gastrointestinal disorders, ie, with diarrhea but not constipation and not necessarily suffering from abdominal pain, 72 one was restricted to constipation predominant IBS (IBS-C) patients 65 and 4 included only diarrhea predominant IBS (IBS-D) patients. 62,68,69,80 All studies claimed the use of Rome (II or III) criteria, nevertheless, a more detailed description of the patient population (the number of IBS-D, IBS-C, and mixed IBS [IBS-M] patients) was lacking.…”

Effective Constipation Treatment Changes More Than Bowel Frequency: A Systematic Review and Meta-Analysis

“…48 One study did not differentiate IBS-C from constipation. 52 Sample sizes varied between 7 38 and 1348, 25 exceeding 100 in 10 of the publications (Table 1).…”

“…27,40 One additional study reported slightly higher rates of discomfort in a placebo-treated cohort. 48 …”

Uso de probióticos en síndrome de intestino irritable y enfermedad inflamatoria intestinal: una revisión de la literatura

“…En ambos trabajos concluyeron que se observa una mejoría clínica significativa luego del consumo de probióticos, teniendo en cuenta el dolor abdominal y diarrea al comparar con el consumo de placebo (27)(28)(29)(30)(31)(32). La Tabla 1 resume los hallazgos de los estudios clínicos incluidos en los metaná-lisis previamente mencionados.…”

“…con una mejoría clínica hasta de 80% en pacientes tratados (15,17,34,37). En cuanto al SII, en la mayoría de artículos estudiados se establece una asociación entre el consumo de probióticos y la mejoría subjetiva y objetiva de sus síntomas cardinales, valorados tanto por cuestionarios subjetivos como por la escala de Bristol (calidad de deposiciones) (13,17,32).…”