BackgroundAdequate bowel preparation is required for magnetic resonance enterography (MRE), which can be achieved by administering contrast solution after mid-gut tubing or taking contrast solution orally. We present the design of randomized controlled trial (RCT) to compare the efficacy and compliance of bowel preparation between mid-gut tubing and oral administering for MRE in patients with Crohn’s disease (CD).Methods/designThis is an open-label, multicenter RCT. Ninety-six patients with CD in need of MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition), aged ≥ 14 years, will be included. Patients will be randomized 1:1 into either bowel preparation by oral administering (oral group) or bowel preparation through mid-gut transendoscopic enteral tubing (TET) (tubing group). The primary outcome measures are: (1) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade scale (1 = few, 5 = very severe); and (2) grade of bowel distention evaluated by a 5-grade scale (1 = 0–20% segmental distention, 2 = 20–40% distention, 3 = 40–60% distention, 4 = 60–80% distention, 5 = 80–100% distention). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by colonoscopy which is evaluated by a 5-point scale.DiscussionThe outcome of this study is expected to provide a novel effective clinical protocol of bowel preparation for MRE in patients with CD. We hope to highlight the concept of physician–patient satisfaction based on different methods of bowel preparation for MRE.Trial registrationClinicalTrials.gov, NCT03541733. Registered on 30 May 2018.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3101-x) contains supplementary material, which is available to authorized users.
Summary
The efficacy of faecal microbiota transplantation (FMT) in Crohn’s disease (CD) remains unclear due to lack of data. This study aimed to assess the value of FMT in treating CD‐related clinical targets. The use of FMT for CD as a registered trial (NCT01793831) was performed between October 2012 and December 2017. Seven therapeutic targets included abdominal pain, diarrhoea, hematochezia, fever, steroid‐dependence, enterocutaneous fistula and active perianal fistula. Each target was recorded as 1 (yes) or 0 (no) during the long‐term follow‐up for each patient. The primary outcome was the rate of improvement in each therapeutic target. Overall, 174 patients completed the follow‐up. The median follow‐up duration was 43 (interquartile range, 28–59) months. The median score of the total targets was 2 (range, 1–4) before FMT, and it decreased significantly at 1, 3, 6, 12, 24 and 36 months after FMT (P < 0.001 respectively). At 1 month after FMT, 72.7% (101/139), 61.6% (90/146), 76% (19/25) and 70.6% (12/17) of patients achieved improvement in abdominal pain, diarrhoea, hematochezia and fever respectively. Furthermore, 50% (10/20) of steroid‐dependent patients achieved steroid‐free remission after FMT. The present findings indicate that it is important to understand the efficacy of FMT in CD as a targeted therapy, especially for abdominal pain, hematochezia, fever and diarrhoea.
INTRODUCTION:
The previous researches aimed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for ulcerative colitis (UC) in a short-term observation. The present study aimed to explore the optimum timing of FMT for maintaining the long-term clinical benefits and to target the gut microbiota that may help to predict the long-term success or failure of FMT in UC.
METHODS:
Two hundred two patients with UC were recruited from November 2012 to September 2018. The primary endpoint of this study was the maintaining time of the first and second courses of FMT. Relapse was defined as partial Mayo score ≥2 after achieving clinical remission and an increase of partial Mayo score ≥1 after achieving clinical response. The stool samples were analyzed by 16S rRNA gene sequencing.
RESULTS:
The median maintaining time of the efficacy was 120 days (IQR, 45–180) and 182.5 days (IQR, 105–311.25) from the first course and second course of FMT, respectively. No FMT-related serious adverse events were observed. The differences of the relative abundance in
Eggerthella
,
Lactobacillus
, and
Ruminococcus
between pre-FMT and 5 days post-FMT were remarkably correlated with the long-term clinical remission (
P
< 0.05).
DISCUSSION:
This study demonstrated that patients with UC should undergo the second course of FMT within 4 months after the first course of FMT for maintaining the long-term clinical benefits. The short-term alterations of microbiota after FMT may be conducive to predicting the long-term efficacy of FMT in UC (see Visual Abstract, Supplementary Digital Content,
http://links.lww.com/CTG/A363
).
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Background:The causal effects of individual risk factors of metabolic syndrome on erectile dysfunction (ED) are still unclear.Objectives: To evaluate the causal effect of risk factors of metabolic syndrome on ED through Mendelian randomization (MR).
Materials and methods:Data for risk factors were obtained from multiple databases with 173,082-757,601 individuals, and that for ED were collected from a genomewide association study including 223,805 Europeans. We performed univariate MR analysis using inverse-variance weighted, MR-Egger, weighted-median, weighted mode methods and multivariable MR analysis to evaluate the total and direct causal effects.
Results:The univariable MR supported that type 2 diabetes mellitus (odds ratios[OR] = 1.14, 95% confidence intervals [CI]: 1.08-1.21, p < 0.001) and body mass index (BMI) (OR = 1.27, 95% CI: 1.12-1.44, p < 0.001) were associated with ED. After excluding the SNPs associated with BMI and other risk factors, the results of multivariable MR for T2D (OR = 1.15, 95% CI: 1.05-1.25, p = 0.001) remained consistent. However, the results of multivariable MR provided limited evidence for the causality between BMI and ED (OR = 1.06, 95% CI: 0.88-1.29, p = 0.532). For systolic blood pressure and lipid components (low-density lipoprotein, high-density lipoprotein and triglycerides), both univariable and multivariable MR failed to offer sufficient evidence to confirm their causal effect on ED.
Conclusion:T2D showed a direct causal effect on ED independent of obesity and dyslipidemia.
Objectives
The way to improve the long-term efficacy of fecal microbiota transplantation (FMT) in ulcerative colitis (UC) remains unclear. This study mainly dedicated to the UC patients’ satisfaction with FMT and the importance of patients’ adherence to repeated FMT for long-term clinical outcomes.
Methods
Patients with UC who underwent FMT at our center from November 2012 to September 2018 were included. We assessed patient satisfaction with efficacy, safety, and reliability of FMT, as well as adherence to the repeated FMT.
Results
One hundred and seventy-six patients were included in the analysis. The median follow-up duration of the study was 25.5 (interquartile range 13.0–46.5) months. The clinical response rate at 1 week, 1 month, 3 months, and 6 months after FMT was 48.9%, 69.3%, 49.4%, and 32.7%, respectively. 3.4% (6/176) of patients underwent colectomy after FMT during our long-term follow-up. Partial Mayo score at 1-month post-FMT (P < 0.001) was an independent factor of patients’ satisfaction. The laboratory preparation process was related to the incidence of adverse events (P < 0.05). 23.8% (29/122) of patients with a good adherence followed our recommendation to undergo the second course of FMT and achieved a longer clinical response compared with the patients with poor adherence (P < 0.001).
Conclusion
Patients’ good adherence to repeated FMT is important to maintain long-term clinical benefits achieved from FMT in UC. Registration number: NCT01790061.
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