Theresa Han-Markey

A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D

Objectives:There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients.Methods:This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3–4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires.Results:After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating, consistency, frequency, and urgency than the mNICE diet.Conclusions:In this US trial, 40–50% of patients reported adequate relief of their IBS-D symptoms with the low FODMAP diet or a diet based on modified NICE guidelines. The low FODMAP diet led to significantly greater improvement in individual IBS symptoms, particularly pain and bloating, compared with the mNICE diet.

Use of Cholecystokinin to Prevent the Development of Parenteral Nutrition-Associated Cholestasis

BACKGROUND Neonates are at high risk for the development of parenteral nutrition-associated cholestasis when receiving a prolonged course of total parenteral nutrition (TPN). Although this cholestasis is of unknown etiology, it may result from a lack of gastrointestinal hormone formation, including cholecystokinin, which normally occurs after enteral feedings. METHODS Two groups of neonates were studied. The treatment group consisted of 21 consecutive, prospectively enlisted neonates receiving TPN for > 14 days. The nontreatment group consisted of 21 infants from the 2 years preceding the study who were matched to the treatment group by gestational age, diagnosis, and duration of TPN. The major outcome determinant was direct bilirubin. Cholestasis was defined as a direct bilirubin > 2.0 mg/dL and was considered severe if the direct bilirubin was > 5.0 mg/dL after other causes were ruled out. RESULTS The mean direct bilirubin levels in the nontreated group progressively rose over time, whereas the mean direct bilirubin the treated group remained level. The incidence of infants with a direct bilirubin > 2.0 mg/dL was 24% and 43% in the CCK+ and CCK- groups, respectively, and was not significant (p = .14). The percentage of infants with a direct bilirubin > 5.0 mg/dL was 9.5% and 38% in the treatment and nontreatment groups, respectively, and was significant, p = .015. CONCLUSIONS Levels of direct bilirubin were lower in the treated compared with the nontreated group. These findings suggest that cholecystokinin prophylaxis in high-risk neonates may help prevent the development of parenteral nutrition-associated cholestasis.

Treatment of parenteral nutrition-associated cholestasis with cholecystokinin-octapeptide.

The authors investigated whether parenteral nutrition-associated cholestasis (PNAC) in surgical neonates could be alleviated by the administration of cholecystokinin-octapeptide (CCK). Two groups of infants were studied, after major abdominal or cardiac surgery in the newborn period. The low-dose group consisted of three infants with PNAC who received cholecystokinin-octapeptide (Sincalide) at a dose of 0.02 micrograms/kg intravenously (IV), twice daily. The high-dose group comprised eight infants with PNAC who received an initial dose of 0.02 micrograms/kg IV or intramuscularly, three times daily on the first day, followed by a daily doubling of the dose up to as high as 0.32 micrograms/kg. In the low-dose group, direct bilirubin levels declined a mean of 50.2 +/- 14.5%. In the high-dose group, direct bilirubin levels declined a mean of 23.4 +/- 14.3%. In three patients in the high-dose group, no decline occurred. All three had clinical signs of overt liver failure and died of liver failure within 2 months after treatment with CCK. By excluding these patients from the high-dose group, the decline in bilirubin levels increased to 49.6 +/- 10.9%. Side effects from CCK occurred in two patients and consisted of abdominal pain and feeding intolerance. Treatment with CCK appears to be associated with a decline in direct bilirubin levels, provided overt liver failure has not developed.

A Diet Low in Fermentable Oligo-, Di-, and Monosaccharides and Polyols Improves Quality of Life and Reduces Activity Impairment in Patients With Irritable Bowel Syndrome and Diarrhea

BACKGROUND & AIMS: We investigated the effects of a diet low in fermentable oligo‐, di‐, and monosaccharides and polyols (FODMAPs) vs traditional dietary recommendations on health‐related quality of life (QOL), anxiety and depression, work productivity, and sleep quality in patients with irritable bowel syndrome and diarrhea (IBS‐D). METHODS: We conducted a prospective, single‐center, single‐blind trial of 92 adult patients with IBS‐D (65 women; median age, 42.6 years) randomly assigned to groups placed on a diet low in FODMAPs or a modified diet recommended by the National Institute for Health and Care Excellence (mNICE) for 4 weeks. IBS‐associated QOL (IBS‐QOL), psychosocial distress (based on the Hospital Anxiety and Depression Scale), work productivity (based on the Work Productivity and Activity Impairment), and sleep quality were assessed before and after diet periods. RESULTS: Eighty‐four patients completed the study (45 in the low‐FODMAP group and 39 in the mNICE group). At 4 weeks, patients on the diet low in FODMAPs had a larger mean increase in IBS‐QOL score than did patients on the mNICE diet (15.0 vs 5.0; 95% CI, –17.4 to –4.3). A significantly higher proportion of patients in the low‐FODMAP diet group had a meaningful clinical response, based on IBS‐QOL score, than in the mNICE group (52% vs 21%; 95% CI, –0.52 to –0.08). Anxiety scores decreased in the low‐FODMAP diet group compared with the mNICE group (95% CI, 0.46–2.80). Activity impairment was significantly reduced with the low‐FODMAP diet (–22.89) compared with the mNICE diet (–9.44; 95% CI, 2.72–24.20). CONCLUSIONS: In a randomized, controlled trial, a diet low in FODMAPs led to significantly greater improvements in health‐related QOL, anxiety, and activity impairment compared with a diet based on traditional recommendations for patients with IBS‐D. ClinicalTrials.gov, number NCT01624610.

821 A Low FODMAP Diet Improves Quality of Life, Reduces Activity Impairment, and Improves Sleep Quality in Patients With Irritable Bowel Syndrome and Diarrhea: Results From a U.S. Randomized, Controlled Trial

Background: In addition to characteristic GI symptoms, irritable bowel syndrome (IBS) patients have incraesed psychological comorbidity and sleep disturbance as well as reduced health-related quality of life (HRQOL), and work productivity relative to the general population. We assessed the impact of a low FODMAP diet versus a control diet on HRQOL, psychological distress, work productivity, and sleep quality measures in patients with IBS and diarrhea (IBS-D). Methods: We conducted a prospective, single center, single-blind randomized controlled trial of adult patients with IBS-D (Rome III). After completing a 2week screening period, eligible patients (mean daily abdominal pain score ≥4 & Bristol stool scale score of ≥5) were randomized to 4-weeks of a low FODMAP diet (LFD) or a control diet based upon modified NICE guidelines. Foods containing FODMAPs were not specifically excluded from the control diet. Both dietary interventions were administered by experienced research dietitians. HRQOL (IBS-QOL), psychosocial distress (Hospital Anxiety and Depression Scale (HADS)), work productivity (Workplace Activity Impairment (WPAI)), and an assessment of sleep quality were conducted before and after the dietary intervention. Fatigue and sleep quality were assessed daily over the study period. Results: Of the 171 subjects consented for enrollment, 92 (65 women (71%), median age 42.6 years (range = 19 -75 years), 68 Caucasian (74%)) were eligible for randomization based upon the baseline assessment. Eighty-three patients completed the study period (45 LFD, 38 control). Demographics, baseline symptom severity, and baseline HRQOL measures were similar between groups. Baseline energy, nutrient, and FODMAP intake were similar between groups. At 4 weeks, the proportion of patients with a >10-point improvement in IBS-QOL score was significantly greater in the LFD group compared to the control group (58% v 24%, p=0.0032). Similarly, the mean total IBS-QOL score at 4 weeks was higher in the LFD v control (p=.0228). Significant improvements were observed in several IBS-QOL domains ( Table 1). There was a trend towards improvement in anxiety for the LFD vs. the control diet which did not reach statistical significance (7.73 v 9.26, p=0.0679). For WPAI, only activity impairment significantly improved (LFD 29.29 v control 41.90, p=0.0398). There was no difference between the two groups for fatigue but sleep quality improved in the LFD compared to the control diet (6.33 v 7.46, p=0.0336). Conclusion: In this US randomized, controlled study of IBS-D patients, a low FODMAP diet improved HRQOL, activity impairment, and sleep quality when compared to a control diet. This is one of the first methodologically rigorous clinical trials to show that diet-based therapy can not only improve symptoms but also HRQOL in patients with IBS-D. Table. IBS QOL means after dietary intervention.

P02.53. Examination of the association of diet on persistent cancer related fatigue

Methods A cross-sectional study was conducted to examine possible associations between diet and fatigue. Dietary intake using a 4-day food diary was assessed in 40 cancer survivors. Cancer survivors had completed all cancer treatments at least 12 weeks prior and had their fatigue assessed with the Brief Fatigue Inventory (BFI). Participants were placed into one of three fatigue levels, “no fatigue”, “moderate fatigue”, or “severe fatigue” based on their BFI. Mean differences in food group, eating patterns and nutrient intake were analyzed using ANOVAs, K-means cluster analysis, chisquares and proportional odds model.