Introduction

Few studies have evaluated the efficacy of butyric acid in treating children with inflammatory bowel disease (IBD).

Aims & Methods

In children and adolescents with recently diagnosed IBD, the purpose of this research was to assess the efficacy of oral sodium butyrate as an adjunct to conventional treatment.This trial was unicentric, prospective, randomised, and placebo controlled. 150 mg sodium butyrate single dose (group A) or a placebo (group B) were randomly assigned to patients with ulcerative colitis or Crohn's disease aged 7–18 years who were receiving conventional medication based on the severity of their conditions. Disease activity, C-reactive protein (CRP), and faecal calprotectin concentration differences between the two study groups at 12 weeks of the trial were the main outcomes.

Results

With 44 patients in group A and 44 in group B, 88 individuals with initially active illness finished the research. Most patients experienced remission by week 12 of the study (36 patients in Group A with sodium butyrate-82%, and 11 patients in Group B with placebo-48%). Between the two groups, a significant difference in disease activity was seen (p = 0.001), with a signifigant higher percent of cases in remission among those from lot A that received sodium butirate compared to placebo. The sodium butyrate group appeared to have less systemic inflammation than the other group, as evidenced by the significantly lower CRP levels in Group A (18.14 ± 11.19 mg/L) compared to Group B (57.00 ± 33.28 mg/L) at 12 weeks (T2) (P < 0.001). No negative effects were recorded by any of the patients. Fecal calprotectin in Group A dropped much more after 12 weeks (T2) (P < 0.001), suggesting that the sodium butyrate group was better able to regulate intestinal inflammation.

Conclusion

In newly diagnosed children and adolescents with IBD, a 12-week sodium butyrate supplementation did demonstrate effectiveness as an additional treatment and decreased the rate of relapsing cases.

Disclosure

Nothing to disclose

Introduction

Surgical management of hemorrhoidal disease (HD) in patients with inflammatory bowel disease (IBD) remains controversial due to concerns about impaired wound healing and disease flare, especially in Crohn’s disease (CD). In Europe, current evidence is mainly based on small historical single-center case series.¹

Aims & Methods

We sought to evaluate the safety and effectiveness of surgical treatments for HD in IBD patients and identify potential risk factors for complications. HEAD-IBD is a retrospective cohort study promoted by the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) and the Italian Society of Colorectal Surgery (SICCR). Patients with established IBD who underwent surgery for HD between December 2004 and March 2024 were included. Data were collected across multiple centres using the REDCap system. IBD activity was measured by the Harvey-Bradshaw Index for CD and the partial Mayo score for ulcerative colitis (UC). Surgical techniques, short- and long-term complications, disease flare, and continence status were analyzed. Only patients with ≥1 year follow-up were considered.

Results

A total of 38 patients were initially identified from 8 centres. Two patients with unclassified IBD were excluded from stratified analysis, leaving 36 patients (Table 1): 21 (58%) with UC and 15 (42%) with CD. Overall, 53% were male. The median age at surgery was 49 years (IQR 13) in UC and 37 years (IQR 22) in CD. At the time of surgery, biologic therapy was ongoing in 10% of UC and 40% of CD patients. Clinically active disease at the last gastroenterology visit was reported in 6 CD patients (40%) and 5 UC patients (24%). The time interval between the last IBD evaluation (clinical or endoscopic) and surgery was significantly longer in UC compared to CD patients (table 1). Distribution of Goligher grade suggested a higher proportion of grade III–IV disease in UC (72%) than in CD (53%). Open hemorrhoidectomy was the most frequent procedure in both groups (66% UC, 73% CD). Non-excisional techniques (DG-HAL +/- mucopexy) were used in 29% of UC and 27% of CD patients. Stapled hemorrhoidopexy was performed only in UC (10%). Median hospital stay was 1 day (IQR 1) in both groups. No 30-day or 6-month postoperative complications were reported in CD, while 14% of UC patients experienced early or mid-term complications. One UC patient experienced IBD flare at 6 months. At 12-month follow-up, one UC patient reported new-onset soiling; continence was otherwise preserved in all cases.

Conclusion

This multicenter study represents the largest European series on surgical treatment of HD in patients with IBD, confirming its safety, with low complication rates and no new perianal disease. Short- and mid-term complications occurred only in UC patients, possibly reflecting both more advanced HD (Goligher grade III–IV) and less intensive preoperative monitoring. These findings highlight the need for close gastroenterological pre-operative assessment and shared decision-making. The ongoing HEAD-IBD II prospective study will provide further insight into optimal management strategies.

References

1. Grossi U, Gallo G, Di Tanna G, et al. Surgical Management of Hemorrhoidal Disease in Inflammatory Bowel Disease: A Systematic Review with Proportional Meta-Analysis. J Clin Med. 2022 Jan 28;11(3):709. doi: 10.3390/jcm11030709

Disclosure

None

Introduction

Mesalazine suppositories are recommended in guidelines for the induction and maintenance of remission in patients with ulcerative proctitis (UP). Nevertheless, nonadherence can be frequent and the recommended dose of mesalazine suppositories in maintenance treatment remains unknown.

Aims & Methods

The aim of this study was to determine the frequency of non-adherence to mesalazine suppositories, evaluate potential factors for nonadherence and the impact on quality of life and number of relapses in patients with UP.
Methods: A multicenter, prospective observational study was designed in patients ≥18 years old with UP under maintenance treatment with mesalazine suppositories (Claversal© 500 mg, Pentasa© 1g or Salofalk©1g). We evaluated adherence, socio-demographic data and complications associated with poor adherence at 6 and 12 months. Adherence was assessed by tracking pharmacy refills (medication possession ratio, MPR). We defined good adherence as MPR ≥80% over 12 months. Health-Related Quality of Life (HRQoL) was evaluated using the disease-specific shortened Spanish version of the IBDQ (SIBDQ-9). Relapse was defined as partial Mayo ≥2; biological remission as a partial Mayo score <2 and fecal calprotectin ≤150. Multivariate analysis allowed us to determine the risk factors for non-adherence to mesalazine suppositories.

Results

A total of 188 patients with mean age 51 were consecutively included across 14 Spanish hospitals (Table 1). Of these, mean MPR was 76% and 56% presented MPR ≥80%. Mean age was higher among patients with MPR ≥80% (p=0.045). A total of 125 (71,4%) patients were in biological remission, 31 patients (16%) had a relapse and 3 (1.6%) patients were hospitalized during the follow-up. The use of corticosteroids during the follow-up (OR=4.25, p=0.041) were associated with better adherence. There were no differences between the different brands and doses of suppositories analyzed. Low adherence was not related with increased number of flares (p=0.927), hospitalizations (p=0.225) or decreased quality of life (p = 0.353) over the 12 months of follow-up.

Conclusion

Almost half of patients with UP on maintenance treatment with mesalazine suppositories have low adherence. The use of oral corticosteroids during the follow-up may increase adherence, but poor adherence to mesalazine suppositories was not related with risk of relapse, hospitalizations or worst quality of life.

Disclosure

Manuel Barreiro de Acosta: speaker, consultant and advisory member for or have received research funding from AbbVie, Janssen, Takeda, Pfizer, Lilly, Alphasigma, Sandoz and Oncostellae