Faecal microbiota transplantation may Improve Gastrointestinal Symptoms in Type 1 Diabetes Patients: Study

A randomized, double-blinded, placebo-controlled pilot trial was conducted to investigate the effect of FMT on gastrointestinal symptoms and quality of life in patients with T1DM. 20 adults with T1DM and moderate to severe gastrointestinal symptoms were randomized in a 1:1 ratio to receive either encapsulated FMT or placebo. The FMT capsules contained an approximately 50-g portion of fecal material, and the placebo capsule contained a combination of glycerol, saline, and food coloring. Each treatment was administered as a single dose, with approximately 25 capsules per person.

The primary endpoint was the count of adverse events of grade 2 or more within one week of intervention as assessed by Common Terminology Criteria for Adverse Events (AEs). Secondary endpoints (SAEs) included changes in gastrointestinal symptoms and quality of life, which were evaluated four weeks post-treatment using validated scales.

Key Findings

Adverse Events:

A total of 26 AEs grade 2 or higher had been found in which 7 SAEs related to 4 patients in FMT group compared with 5 patients and 19 events in a placebo group; common AEs were diarrhea and bloating, however, no such serious adverse effects associated with the interventions were observed.

GI Symptoms Improvement :

• The patients in the FMT group showed a significant decrease in median GSRS-IBS scores, from 58 (IQR 54–65) to 35 (32–48). In contrast, the scores of the placebo group decreased from 64 (55–70) to 56 (50–77) (p = 0.01).

Quality of Life Improvement:

• In FMT recipients, the Irritable Bowel Syndrome Impact Scale score improved from 108 (101–123) to 140 (124–161). Conversely, in the placebo group, their score improved from 77 (53–129) to 92 (54–142) (p=0.02).

Reduced Severity Index:

• The scores of the PAGI-SS declined significantly after FMT, from a median of 42 (28–47) to 25 (14–31). In contrast, the placebo group saw a smaller reduction from 47 (31–69) to 41 (36–64) (p = 0.03).

FMT can be a safe and effective treatment for the alleviation of GI symptoms in patients with type 1 diabetes. Symptomatic severity, quality of life, and overall gastrointestinal health were improved in patients who underwent FMT in comparison with those receiving a placebo. These results open up avenues for further, larger-scale validations of FMT as a standard therapy for diabetic gastroenteropathy.

Reference:

Høyer, K. L., Dahl Baunwall, S. M., Kornum, D. S., Klinge, M. W., Drewes, A. M., Yderstræde, K. B., Thingholm, L. B., Mortensen, M. S., Mikkelsen, S., Erikstrup, C., Hvas, C. L., & Krogh, K. (2025). Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trial. EClinicalMedicine, 79(103000), 103000.https://doi.org/10.1016/j.eclinm.2024.103000