Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn’s disease: a prospective trial (Mar 2025, n=49) "remission rates did not differ between the two groups" FMT

[Michael Harrop]

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05832-1

lyophilized, acid-resistant capsules. 150 mg/capsule; 60 capsules per course. Five capsules were administered twice a day for 6 consecutive days. The capsules were taken on an empty stomach after awakening in the morning and before going to bed at night.

A laxative (compound polyethylene glycol 4000, 64 g) was administered one night before FMT capsule treatment. The patients were administered periodic capsule therapy at weeks 0 (baseline) and 5.

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The donors were healthy children of a similar age to the patients, and the screening criteria and fresh fecal bacteria were prepared as previously described [14].

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No serious AEs were observed after oral administration of the FMT capsules. However, mild AEs were observed in 10 patients (58.8%), including constipation (nine patients), mild abdominal pain, fatigue, and alopecia, most of which occurred approximately 10 days after the first course of oral FMT capsules. Most of these symptoms were self-limiting and did not require pharmacological intervention. Among the patients, four with constipation required treatment with lactulose to improve their symptoms. Seven days later, the constipation symptoms improved. After the second course of oral capsules, three patients developed constipation again, while the other patients did not experience any discomfort (Table 1).

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Abstract​

Background​

Clinical data on oral fecal microbiota transplantation (FMT), a promising therapy for Crohn’s disease (CD), are limited. Herein, we determined the short-term safety and feasibility of FMT for pediatric patients with active CD.

Methods​

In this open-label, parallel-group, single-center prospective trial, patients with active CD were treated with oral FMT capsules combined with partial enteral nutrition (PEN) (80%). The control group comprised pediatric patients with active CD treated with PEN (80%) and immunosuppressants. Thirty-three patients (11.6 ± 1.82 years)—17 in the capsule and 16 in the control groups—were analyzed. Data regarding the adverse events, clinical reactions, intestinal microbiome composition, and biomarker parameters were collected and compared post-treatment.

Results​

At week 10, the clinical and endoscopic remission rates did not differ between the two groups. By week 10, the mean fecal calprotectin level, C-reactive protein level, erythrocyte sedimentation rate, simple endoscopic score for CD, and pediatric CD activity index decreased significantly in the capsule group (all P < 0.05). The main adverse event was mild-to-moderate constipation. Core functional genera, Agathobacter, Akkermansia, Roseburia, Blautia, Subdoligranulum, and Faecalibacterium, were lacking pre-treatment. Post-treatment, the implantation rates of these core functional genera increased significantly, which positively correlated with the anti-inflammatory factor, interleukin (IL)-10, and negatively correlated with the pro-inflammatory factor, IL-6. The combination of these six functional genera distinguished healthy children from those with CD (area under the curve = 0.96).

Conclusions​

Oral FMT capsules combined with PEN (80%) could be an effective therapy for children with active CD. The six core functional genera identified here may be candidate biomarkers for identifying children with CD.

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