Intervention Study Focused on the Intestinal Microbiome to Evaluate the Impact of a Wild Thyme Extract (Thymus Serpyllum) Extract With Anti-inflammatory and Metabolic Properties Against Functional Gastrointestinal Disorders.

Condition(s) studied

Investigational drug(s) / intervention(s)

Wild thyme extract: All patients will be randomized (1:1) to receive the active thyme extract (600 mg/capsule/day or 600 mg/capsule/day of microcrystalline cellulose) in the form of capsules, administered orally and daily for 2 months

Placebo: 600 mg/day microcrystalline cellulose

Study summary

Functional gastrointestinal disorders (FGD), now known as disorders of gut-brain interactions (DGBI), are characterized by gastrointestinal symptoms linked to motility issues, visceral sensitivity, intestinal permeability, immune activation, neuroendocrine function, CNS processing, and gut microbiota. These disorders include symptoms like abdominal pain, diarrhea, constipation, bloating, fullness, nausea, and vomiting, associated with conditions like IBS and functional dyspepsia. The complex pathophysiology of FGDs is not fully understood, affecting one-third of gastroenterology consultations. Diagnosis and treatment follow Rome Foundation criteria, focusing on symptom management rather than underlying mechanisms. Nearly half the population will meet FGD criteria at some point, with significant overlap in symptoms and conditions.

The gut microbiota's role is crucial, affecting homeostasis and linked to FGDs through dysbiosis. Treatments include antibiotics, dietary changes, and fecal transplants. Prebiotics, including medicinal plant extracts like wild thyme (Thymus serpyllum L.), show promise. Wild thyme has traditionally treated respiratory and gastrointestinal issues and contains phenolic compounds with potential spasmolytic and antioxidant effects.

Preclinical studies show wild thyme extract benefits in inflammation, IBS, and metabolic syndrome models. Recent human trials indicate improvements in gut regularity and microbiota. This study proposes wild thyme extract as a dietary supplement to benefit digestive health in FGDs, hypothesizing its immunomodulatory and prebiotic properties can reduce inflammation and restore microbiota balance. Specific objectives include analyzing microbiome impact, barrier function, inflammation, and identifying prognostic biomarkers to predict treatment response.

Eligibility

Primary outcome measure(s)

• Evaluation of the composition of the intestinal microbiome — From enrollment to the end of treatment at 8 weeks
  Metagenomic studies from feces samples at two different points (initial and final point). Shallow shotgun metagenomic will se used to evaluate the composition of the gut microbiota in these samples.

Trial sites (1)

More Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental trials in Spain