Renal dysfunction in routine proton-pump inhibitor use may be linked to comorbidities: A real-world observational study.

INTRODUCTION: The use of proton-pump inhibitors (PPI) is linked with infrequent but serious adverse events, including acute kidney injury, chronic kidney disease (CKD) and progression of CKD. Data on renal safety in routine use of PPI are more relevant to clinical practice. We studied whether such use of PPI is associated with renal dysfunction. METHODS: Patients taking PPI for at least six weeks had serum creatinine tested pre (n = 200) and post (n = 180) recruitment. These patients were then advised to follow-up: those taking PPI for at least 90 days in the next six months (n = 77) and at least another 90 days in the following six months (n = 50), had serum creatinine tested at such follow-up. Renal dysfunction was defined as any increase in serum creatinine level above baseline. RESULTS: The 200 patients recruited had mean age 39.6 (SD 9.2) years. Ninety-eight (49%) patients had a history of previous PPI use (median six months; interquartile range [IQR] 3-24). Only 20 (11.1%) patients at six weeks, 11 (14.3%) at six months and six (12%) at one year had increase in creatinine level; a majority of them had less than 0.3 mg/dL increase. Ten of these 20 (six weeks), five of 11 (six months) and five of six (one year) had other risk factors for renal dysfunction. No patient developed CKD during the study period. CONCLUSIONS: Mild and non-progressive increase in serum creatinine occurred in 10% to 15% of patients on routine PPI use. A majority of them had other risk factors. Small sample size and short follow-up duration are a few limitations of this study.

Self-reported food intolerances in an Indian population: Need for individualization rather than a universal low-FODMAP diet.

Background and Aim: Low-fermentable oligo-, di-, and monosaccharides and polyol (FODMAP) diets have been recommended for individuals with food intolerance and irritable bowel syndrome (IBS). Individual food intolerances may, however, not correspond to the FODMAP content alone. Methods: We conducted a survey on self-reported intolerance to articles of food commonly identified as high FODMAP in 400 healthy Indian subjects (median age 40 years; 69% men) and 204 consecutive consenting patients with IBS (median age 36 years; 58% men). Results: One-hundred seventy-nine (44.8%) healthy subjects and 147 (72.1%) patients with IBS reported some food intolerance (P < 0.00001); the latter reported intolerance to all items (except nuts) more frequently than healthy subjects. The prevalence, however, varied from 2.5 to 32%. Milk intolerance was reported equally commonly by healthy subjects and patients (23% vs 29.9%). Twenty-three (11.3%) patients and no healthy subjects reported wheat sensitivity. The IBS diarrhea subgroup reported intolerance to milk, pulses, capsicum, cauliflower, leafy vegetables, and dry fruits more frequently than the constipation subgroup. Conclusion: From among a list of high-FODMAP items, individuals' intolerance varied widely, suggesting that individuals should be the final judge in deciding their elimination diets rather than devise them based on the FODMAP content alone. As in the West, food intolerance was reported more commonly by patients with IBS, especially those with diarrhea, than by healthy individuals. Also noteworthy is the low prevalence of milk intolerance in a subcontinent labeled as high in lactose intolerance. Unlike in the West, wheat intolerance was not reported by any healthy individual.

A prospective study of inflammatory bowel disease phenotypes in extremes of age and comparison with adults.

BACKGROUND AND AIMS: Pediatric and elderly inflammatory bowel disease (IBD) are less explored, often in retrospective studies. The pediatric group has a more extensive and aggressive disease phenotype requiring aggressive treatments, whereas the elderly group may have less aggressive diseases. METHODS: We prospectively compared disease characteristics of a single center cohort of IBD patients (pediatric age ≤ 16 years; adults 17 to 59 years; and elderly ≥ 60 years) seen between September 2018 and November 2019 with at least six months of follow-up. RESULTS: Total 266 IBD patients (137 males) included 47 pediatric, 175 adults and 44 elderly patients. Among ulcerative colitis (UC) patients, pancolitis was more common in the pediatric group (p = 0.018), while the elderly group had more indolent behaviors and infrequent extraintestinal manifestations (p = 0.005). Among patients with Crohn's disease (CD), the pediatric group had more often colonic diseases (p = 0.02) and the elderly, ileal diseases (p = 0.04). The disease behavior was similar in the three age groups. Perianal disease was least common in elderly CD patients (p = 0.03). There was no treatment difference among different age groups in UC. In CD, pediatric patients needed biologics more frequently (p = 0.005), while elderly CD patients less frequently required steroids, biologics, immunosuppressants and surgery (p < 0.05). CONCLUSIONS: We noted differences compared to western literature such as colonic location in pediatric CD and ileal location in elderly CD. Perianal disease was less frequent in the elderly CD group. There was no difference in treatment in the three age groups in UC, while there were no inter-age-group disease behavioral differences for UC and CD.

Low prevalence of primary sclerosing cholangitis in patients with inflammatory bowel disease in India.

BACKGROUND/AIMS: Primary sclerosing cholangitis (PSC) represents the most common hepatobiliary extraintestinal manifestation of inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD). Limited data exist on PSC in patients with IBD from India. We aimed to assess the prevalence and disease spectrum of PSC in Indian patients with IBD. METHODS: Database of IBD patients at 5 tertiary care IBD centers in India were analyzed retrospectively. Data were extracted and the prevalence of PSC-IBD was calculated. RESULTS: Forty-eight patients out of 12,216 patients with IBD (9,231 UC, 2,939 CD, and 46 IBD unclassified) were identified to have PSC, resulting in a prevalence of 0.39%. The UC to CD ratio was 7:1. Male sex and pancolitis (UC) or colonic CD were more commonly associated with PSC-IBD. The diagnosis of IBD preceded the diagnosis of PSC in most of the patients. Majority of the patients were symptomatic for liver disease at diagnosis. Eight patients (16.66%) developed cirrhosis, 5 patients (10.41%), all UC, developed malignancies (3 colorectal cancer [6.25%] and 2 cholangiocarcinoma [4.16%]), and 3 patients died (2 decompensated liver disease [4.16%] and 1 cholangiocarcinoma [2.08%]) on follow-up. None of the patients mandated surgical therapy for IBD. CONCLUSIONS: Concomitant PSC in patients with IBD is uncommon in India and is associated with lower rates of development of malignancies.

Ten-day concomitant and sequential therapy for Helicobacter pylori effective in region with high antibiotic resistance rates.

BACKGROUND: Increasing antibiotic-resistant Helicobacter pylori (H. pylori) strains complicate efforts to eradicate infection. In regions with high dual resistance to both clarithromycin and metronidazole, bismuth quadruple therapy is recommended. But, with lack of easy availability of bismuth, the (non-bismuth) concomitant and sequential regimens are used commonly as first-line therapy. Recent reports indicate suboptimal results with sequential therapy in such regions. We aimed to compare the efficacy of concomitant therapy vs. sequential therapy in the eradication of H. pylori in a region with high antibiotic resistance rates, and to compare adherence rates and adverse events with the regimens. METHODS: One hundred and twenty-four consecutive H. pylori-infected patients (diagnosed using rapid urease test or urea breath test) were randomized to receive sequential or concomitant therapy for 10 days each. Four weeks after treatment completion, urea breath test was done to confirm eradication of the infection. Cure rates were compared between the two regimens and note was made of adherence rates and adverse events. RESULTS: Concomitant therapy showed a statistically non-significant higher cure rate compared to sequential therapy in intention-to-treat (87.1% vs. 81.4%%, p = 0.46) and per-protocol (94.7% vs. 83.9%, p = 0.07) analyses. Both the regimens were well tolerated and showed similar adherence rates (p = 1.00) and incidence of adverse events (p = 0.44). CONCLUSION: In a region with high dual resistance, both concomitant and sequential therapy for H. pylori infection achieved eradication rates >80%, but concomitant therapy showed a statistically non-significant higher cure rate, with similar adherence and adverse event profiles.

Self-reported Wheat Sensitivity in Irritable Bowel Syndrome and Healthy Subjects: Prevalence of Celiac Markers and Response to Wheat-free Diet.

BACKGROUND/AIMS: Most patients with irritable bowel syndrome (IBS) report food-related aggravation of symptoms. Wheat/gluten is one of the most commonly incriminated. We studied the prevalence of self-reported wheat sensitivity in patients with IBS and in a healthy population from a region in India consuming mixed-cereal diets, correlated it with serological and human leukocyte antigen (HLA) markers of celiac disease, and evaluated the response to a wheat-free diet. METHODS: We surveyed 204 patients with IBS and 400 healthy persons for self-reported wheat sensitivity. Testing for IgA anti-tissue transglutaminase and HLA DQ2 or DQ8 was done in individuals who reported wheat sensitivity. Consenting persons with wheat sensitivity were put on wheat-free diet and monitored for symptom change. RESULTS: Twenty-three of 204 patients with IBS (11.3%) and none of the healthy subjects self-reported wheat sensitivity. Of 23 patients, 14 (60.9%) were positive for HLA DQ2 or DQ8 and none for anti-tissue transglutaminase antibody. After 6 weeks on wheat-free diet, all 19 participating patients reported clinical improvement; fewer patients had bloating, diarrhea, constipation, and easy fatigue. CONCLUSIONS: Eleven percent of patients with IBS self-reported wheat sensitivity. None of them had positive celiac serology; 60.9% were positive for HLA DQ2 and DQ8, suggesting a possible genetic basis. All of them improved symptomatically on a wheat-free diet.

Long-term outcomes of anti-tumor necrosis factor therapy and surgery in nonperianal fistulizing Crohn's disease.

BACKGROUND: Unlike perianal fistula, long-term outcomes of nonperianal fistulae (NPF) in Crohn's disease (CD) are not clear. We aimed to compare the outcomes of medical and surgical therapies in patients with NPF. METHODS: We retrospectively analyzed the records of patients of CD with NPF who were prospectively followed from January 2005 to December 2018. RESULTS: Of the 53 patients with NPF [mean age at presentation:29 ± 14 years; 54.7% male; median duration of follow-up: 47 months (interquartile range [IQR]:26-76 months)], enteroenteric fistula (37.8%) was the most common presentation. Of 22 patients treated with anti-tumor necrosis factor (TNF) therapy, complete response was achieved in 40.9% (n = 9). Overall probability of maintaining response was similar between the anti-TNF and surgical groups (95.2% vs 82.4%; 71% vs 76%; and 63% vs 69%% [P = 0.8] at 1, 2, and 3 years, respectively), with only 13.6% of patients treated with biologicals requiring surgery over 56 months. Twenty-one patients required upfront surgery (small bowel or ileocolonic resection with/without diversion; 28.5% emergent), with 47.6% postoperative recurrence over 36 months, of which nine patients required biologicals (77.7% response to anti-TNF therapy). Long-term outcome was comparable between medically and surgically treated patients; 6.4% developed tuberculosis on anti-TNF therapy. Two patients (3.7%) developed malignancy (one - enteroenteric, one - colovesical). CONCLUSION: Anti-TNF therapy appears to be as effective as surgery in this retrospective analysis of patients with NPFCD, and it may be indicated in the absence of abscess and other complications. These patients are at higher risk of fistula-associated malignancy, which requires a lower threshold for suspicion, especially over the long term in the presence of nonresponse to medical therapy.

Is the rise in Crohn's disease in India accompanied by a fall in intestinal tuberculosis? A single-center experience.

INTRODUCTION: The relationship between the incidence of intestinal tuberculosis (TB) and Crohn's disease (CD) is interesting, especially considering the striking similarity between the two conditions. Some studies from Asian populations suggested that the incidence of intestinal TB decreases when there is an increase in CD. AIM: To compare the incidence trend between intestinal TB and CD over 15 years. METHODS: Medical records of patients seen in the Division of Gastroenterology over 15 years (2005-2019) were reviewed. CD was diagnosed according to the Copenhagen criteria. Intestinal TB was diagnosed in the appropriate clinical situation if any one or more of the following was present: (1) positive TB MGIT culture; (2) positive Gene Xpert for TB; (3) suggestive histologic findings, with positive tissue acid-fast bacillus (AFB) on smear or with sustained response to anti-TB therapy. The incidence time trend of patients with CD and intestinal TB diagnosis was then studied year-wise. RESULTS: 632 medical case records were accessed; 60 patients were excluded due to inadequate data or not fulfilling diagnostic criteria. The 572 patients included 224 with intestinal TB (median age 37 years, IQR 22; 125 [56%] females) and 348 with CD (median age 40 years, IQR 25; 159 [46%] females [p < 0.02 as compared to TB]). Thus, more patients with CD were seen during the study period, but there was no correlation between the incidence of the two conditions (r = 0.318; p = 0.25). CONCLUSION: In Indian patients in a single private-sector center, there was no inverse correlation between the incidence of intestinal TB and CD over 15 years.