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Clostridium difficile infection can be life-threatening and difficult to treat, with frequent relapses. In this study in patients with recurrent C. difficile –associated diarrhea, infusion of healthy donor feces significantly decreased relapses, as compared with vancomycin therapy. Antibiotic treatment for an initial Clostridium difficile infection typically does not induce a durable response in approximately 15 to 26% of patients. 1 – 3 An effective treatment against recurrent C. difficile infection is not available. Generally, repeated and extended courses of vancomycin are prescribed. 4 The estimated efficacy of antibiotic therapy for a first recurrence is 60%, a proportion that further declines in patients with multiple recurrences. 2 , 5 – 7 Mechanisms that have been proposed for recurrence include persistence of spores of C. difficile, diminished antibody response to clostridium toxins, and persistent disturbance with a reduced diversity of intestinal microbiota. 8 – 12 Infusion of . . .

Background. Fecal transplantation (FT) is a promising treatment for recurrent Clostridium difficile infection (CDI), but its true effectiveness remains unknown. We compared 14 days of oral vancomycin followed by a single FT by enema with oral vancomycin taper (standard of care) in adult patients experiencing acute recurrence of CDI. Methods. In a phase 2/3, single-center, open-label trial, participants from Ontario, Canada, experiencing recurrence of CDI were randomly assigned in a 1:1 ratio to 14 days of oral vancomycin treatment followed by a single 500-mL FT by enema, or a 6-week taper of oral vancomycin. Patients with significant immunocompromise, history of fulminant CDI, or irreversible bleeding disorders were excluded. The primary endpoint was CDI recurrence within 120 days. Microbiota analysis was performed on fecal filtrate from donors and stool samples from FT recipients, as available. Results. The study was terminated at the interim analysis after randomizing 30 patients. Nine of 16 (56.2%) patients who received FT and 5 of 12 (41.7%) in the vancomycin taper group experienced recurrence of CDI, corresponding with symptom resolution in 43.8% and 58.3%, respectively. Fecal microbiota analysis of 3 successful FT recipients demonstrated increased diversity. A futility analysis did not support continuing the study. Adverse events were similar in both groups and uncommon. Conclusions. In patients experiencing an acute episode of recurrent CDI, a single FT by enema was not significantly different from oral vancomycin taper in reducing recurrent CDI. Further research is needed to explore optimal donor selection, FT preparation, route, timing, and number of administrations. Clinical Trials Registration. NCT01226992.

Persistent diarrhea remains medical challenge to date regarding both its etiology and therapeutic interventions. Here, we conducted a randomized, double-blind, controlled clinical trial to evaluate the effectiveness of high-dose multi-strain Bacillus spore probiotics (LiveSpo DIA30) containing B. subtilis , B. clausii , and B. coagulans at 5 billion CFU/5 mL ampoule, in the supportive treatment of persistent diarrhea in children. Our findings revealed a significant 3-day shorter recovery period, 1.60-fold enhanced efficacy, and a 9.47-fold increase in odds (all p- values < 0.0001) for effectively resolving diarrhea by day 5 with the Bacillus spores. Notably, the group receiving LiveSpo DIA30 (Dia30 group) experienced a reduction in antibiotic treatment duration by 2 days compared to the Control group, equivalent to a 25% decrease in antibiotic usage. After 5 days of treatment, LiveSpo DIA30 demonstrated significant reductions in elevated blood pro-inflammatory cytokines, including IL-17 (26.62%; p  = 0.0178), IL-23 (25.13%; p  = 0.0256), TNF-α (19.09%; p  = 0.038), and in fecal sIgA (24.24%; p  = 0.0433). Analysis of 16S rRNA metagenome revealed that Dia30 group exhibited a notable increase in density of Actinomycetota and Bacillota phylum, along with Actinomycetaceae, Lactobacillaceae, and Streptococaceae families. Lacticaseibacillus rhamnosus , a beneficial gut species, was not detectable at day 0 but reached a density of 0.91% ( p  = 0.015) in Dia30 group by day 5. Additionally, Dia30 group showed a significant reduction in density of the Proteobacteria phylum, Enterobacteriaceae family, and harmful species Escherichia fergusoni (682.8-fold; p  = 0.011). In conclusion, this clinical trial presents robust clinical evidence, supported by laboratory testing data, demonstrating the efficacy of multi-strain and high-concentration Bacillus spore probiotics in rapidly alleviating symptoms and reducing antibiotic usage in children with persistent diarrhea. This is archived by improving the native gut microbiota and modulating immunological responses. Trial registration : ClinicalTrials.gov, Identifier No: NCT05812820, 14/4/2023.

Background Pediatric Tuina has been widely used in children with acute diarrhea in China. However, due to the lack of high-quality clinical evidence, the benefit of Tuina as a therapy is not clear. We aimed to assess the effect of pediatric Tuina compared with sham Tuina as an add-on therapy in addition to usual care for 0–6-year-old children with acute diarrhea. Methods Eighty-six participants aged 0–6 years with acute diarrhea were randomized to receive pediatric Tuina plus usual care ( n  = 43) or sham Tuina plus usual care ( n  = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed. Results Pediatric Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT (crude RR, 0.73 [95% CI, 0.59–0.91]) and PP analyses (crude RR, 0.66 [95% CI, 0.53–0.83]). However, the results were not significant when we adjusted for social demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal. Conclusions In children aged 0–6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina . Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy. Trial registration Clinicaltrials.gov, Identifier: NCT03005821 , Data of registration: 2016-12-29.

Over half a million children die each year of diarrheal illness, although nearly all deaths could be prevented with oral rehydration salts (ORS). The literature on ORS documents both impressive health benefits and persistent underuse. At the same time, little is known about why ORS is underused and what can be done to increase use. We hypothesized that price and inconvenience are important barriers to ORS use and tested whether eliminating financial and access constraints increases ORS coverage. In July of 2016, we recruited 118 community health workers (CHWs; representing 10,384 households) in Central and Eastern Uganda to participate in the study. Study villages were predominantly peri-urban, and most caretakers had no more than primary school education. In March of 2017, we randomized CHWs to one of four methods of ORS distribution: (1) free delivery of ORS prior to illness (free and convenient); (2) home sales of ORS prior to illness (convenient only); (3) free ORS upon retrieval using voucher (free only); and (4) status quo CHW distribution, where ORS is sold and not delivered (control). CHWs offered zinc supplements in addition to ORS in all treatment arms (free in groups 1 and 3 and for sale in group 2), following international treatment guidelines. We used household surveys to measure ORS (primary outcome) and ORS + zinc use 4 weeks after the interventions began (between April and May 2017). We assessed impact using an intention-to-treat (ITT) framework. During follow-up, we identified 2,363 child cases of diarrhea within 4 weeks of the survey (584 in free and convenient [25.6% of households], 527 in convenient only [26.1% of households], 648 in free only [26.8% of households], and 597 in control [28.5% of households]). The share of cases treated with ORS was 77% (448/584) in the free and convenient group, 64% (340/527) in the convenient only group, 74% (447/648) in the free only group, and 56% (335/597) in the control group. After adjusting for potential confounders, instructing CHWs to provide free and convenient distribution increased ORS coverage by 19 percentage points relative to the control group (95% CI 13-26; P < 0.001), 12 percentage points relative to convenient only (95% CI 6-18; P < 0.001), and 2 percentage points (not significant) relative to free only (95% CI -4 to 8; P = 0.38). Effect sizes were similar, but more pronounced, for the use of both ORS and zinc. Limitations include short follow-up period, self-reported outcomes, and limited generalizability. Most caretakers of children with diarrhea in low-income countries seek care in the private sector where they are required to pay for ORS. However, our results suggest that price is an important barrier to ORS use and that switching to free distribution by CHWs substantially increases ORS coverage. Switching to free distribution is low-cost, easily scalable, and could substantially reduce child mortality. Convenience was not important in this context. Trial registry number AEARCTR-0001288.

Objectives To compare efficacy and safety of intramuscular (IM) ondansetron with oral ondansetron for improving utilization of Oral Rehydration Therapy (ORT) by controlling vomiting in children with acute diarrhea and some dehydration. Methods We enrolled children aged 3 months to 12 years presenting with acute diarrhea (duration < 14 days) with some dehydration, and at least two episodes of vomiting within last 6 h in an open-label randomized controlled trial. Participants were randomized to receive single dose (0.2 mg/kg) of IM or oral ondansetron before starting ORT. Primary outcome was failure of ORT (persistence of some dehydration after 4 h of ORT or need for intravenous fluids). Secondary outcomes included need for unscheduled intravenous fluids, amount of Oral Rehydration Salt Solution (ORS) ingested after 4 h, frequency of vomiting episodes, adverse effects, and caregiver satisfaction. Results We randomized 60 children (31 IM, 29 oral); 58 (29 per group) were followed-up for all outcomes. There were no significant differences between IM and oral routes in terms of ORT failure (31% vs. 24.1%; RR (95% CI) 1.3 (0.5, 3.0), P  = 0.557), need for IV fluids during ORT (24.1% vs. 20.7%; P  = 0.753), mean (SD) ORS ingested (mL) in 4 h [616.2 (429.7) vs. 645.5 (403.5); P  = 0.79], mean (SD) frequency of vomiting [1.4 (2.0) vs. 2.3 (2.4); P  = 0.107] or caregiver satisfaction. No adverse events attributable to the intervention were observed. Conclusion Intramuscular ondansetron may not offer any advantage over oral use in management of children with acute diarrhea with vomiting and some dehydration. Trial registration Clinical Trials Registry-India (CTRI/2020/01/023082) available at ctri.nic.in.

Treatment with 20 mg of zinc daily for 10 to 14 days in children with acute diarrhea has been shown to improve diarrhea but increase vomiting. In this randomized trial involving children in Tanzania and India, 5 mg and 10 mg of daily zinc were noninferior to 20 mg of zinc for diarrhea and resulted in less vomiting.

Background Low-osmolarity oral rehydration salt (ORS) and zinc therapy effectively manage diarrhea in children under five years of age, offering both short- and long-term benefits. Despite this, caregivers’ adherence to ORS and zinc is often unsatisfactory due to factors such as forgetfulness, resolution of symptoms, and underestimation of the disease’s severity. This study assessed the effect of mobile call reminders on ORS and zinc tablet adherence among children with acute diarrhea in a secondary-level health facility in Kwara State, Nigeria. Methods Using an open-label, randomized controlled trial design, this study compared caregiver-child pairs with acute diarrhea aged 6–59 months who received standard instructions (SI) alone (control group) and an intervention group (IG) who received SI plus phone call reminders on days three and seven of zinc sulfate therapy. All participants used a pictorial diary to track loose/watery stools and ORS and zinc tablet treatments for ten days. The primary outcome measures were independent and combined adherence to ORS and zinc therapy. The secondary outcomes were independent and combined adherence scores, defined as the percentage of times the ORS was given post-diarrhea and the percentage of prescribed zinc tablets administered out of ten. Results A total of 364/400 mother–child pairs completed the study. The percentage of mothers with full adherence in the intervention group was 82.5% for ORS, 72.1% for zinc, and 58.5% for combined use, compared to 78.8%, 60.8%, and 43.6%, respectively, in the control group. The odds of full adherence to ORS and zinc were 1.6 and 1.7 times higher among intervention mothers [ORS: OR = 1.561, 95% CI = 0.939–2.598, P  = 0.085; zinc: OR = 1.671, 95% CI = 1.076–2.593, P  = 0.022], and 1.8 times higher for combined use according to WHO guidelines [OR = 1.818, 95% CI = 1.200–2.754, P  = 0.005]. The mean adherence scores for the intervention group were higher than those for the control group by 4.1% (95% CI = 0.60–7.60) for ORS, 7.3% (95% CI = 3.74–10.86) for zinc, and 5.7% (95% CI = 3.23–8.17) for the combined treatment. Conclusion Phone reminders can effectively improve consistency of home treatment administered by caregivers for children under five years old. Trial Registration The study was registered retrospectively (17/3/2023) with the Pan African Clinical Trial Registry (PACTR202301560735856).

Background Diarrhea is frequent in patients in intensive care units (ICU) and is associated with discomfort and complications and may increase the length of stay and nursing workload. Methods This was a prospective, double-blind, randomized, controlled single-center pilot study to assess the incidence and frequency of diarrhea and the respective effects of a modified enteral diet (intervention: Peptamen® AF, rich in proteins, medium chain triglycerides and fish oil) compared to a standard diet (control: Isosource® Energy) in 90 randomized adult patients (intervention, n  = 46; control, n  = 44) with an ICU stay ≥5 days and tube feeding ≥3 days. Tube feeding was initiated within 72 h of ICU admission and continued up to 10 days. The caloric goal was adjusted to needs by indirect calorimetry. Gastrointestinal function, nutritional intake, and nursing workload were recorded. Follow-up was until 28 days after randomization. Results Median age was 63.3 (interquartile range (IQR) 51.0–73.2) years and Simplified Acute Physiology Score (SAPS) II was 61.0 (IQR 47.8–74). Time to reach caloric goal (intervention: 2.2 (0.8–3.7) days (median, IQR); control: 2.0 (1.3–2.7) days; p  = 0.16), length of time on study nutrition (intervention: 5.0 (3.6–6.4) days; control: 7.0 (5.3–8.7) days; p  = 0.26), and calorie intake (intervention: 18.0 (12.5–20.9) kcal/kg/day; control 19.7 (17.3–23.1) kcal/kg/day; p  = 0.08) did not differ between groups, with a higher protein intake for Peptamen® group (1.13 (0.78–1.31) g/kg/day vs 0.80 (0.70–0.94); p  < 0.001). No difference in diarrhea incidence (intervention group: 29 (64%); control group: 31 (70%); p  = 0.652), use of fecal collectors (23 (51%) vs. 24 (55%); p  = 0.83), or diarrhea-free days (161 (64%) vs 196 (68%); p  = 0.65) was found. Nursing workload and cost for diarrhea care were not different between the groups. In a post-hoc analysis, adjusted for treatment group, age, sex, and SAPS II score, diarrhea was associated with length of mechanical ventilation (9.5 (6.0–13.1) vs. 3.9 (3.2–4.6) days; p  = 0.006) and length of ICU stay (11.0 (8.9–13.1) vs. 5.0 (3.8–6.2) days; p  = 0.001). Conclusions In this pilot study, we found a high incidence of diarrhea, which was not attenuated by Peptamen® AF. Patients with diarrhea stayed longer in the ICU. Trial registration ClinicalTrials.gov identifier, NCT01581957 . Registered on 18 April 2012.

Acute gastroenteritis is a common illness, and treatment with probiotics is common. In a double-blind, placebo-controlled trial, treatment with Lactobacillus rhamnosus GG was found to afford no benefit in reducing symptoms associated with acute gastroenteritis in children.