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.

NCT06639126 | Enrolling By Invitation DMC

• 1 other identifier: FIBAO-UGR
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Gastrointestinal Disorders

Keywords

Intestinal microbiota; Functional dyspepsia; Thymus vulgaris; Functional gastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

• Evaluation of the composition of the intestinal microbiome

  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.

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo treated with 600 mg/capsule/day of microcrystalline cellulose

Other: Placebo

Active

EXPERIMENTAL

Group with wild thyme extract

Dietary Supplement: Wild thyme extract

Interventions

Wild thyme extract DIETARY_SUPPLEMENT

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

Also known as: 600 mg/capsule/day of microcrystalline cellulose, 600 mg/capsule/day of thyme extract

Active

Placebo OTHER

600 mg/day microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of functional gastrointestinal disorder.

You may not qualify if:

• Obesity.
• Antibiotic treatment.
• Pregnancy.
• Clinical diagnoses of Inflammatory bowel disease.
• Clinical diagnosis of Celiac disease
• Clinical diagnosis of Hematological pathologies.
• Clinical diagnosis of Autoimmune or immunodeficiency diseases.
• Treatments with opioids, prokinetics, laxatives, antispasmodics, NSAIDs and proton pump inhibitors (PPIs).

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: lead

Study Sites (1)

Alba Rodriguez Nogales

Granada, Granada, 18198, Spain

Location

Related Publications (6)

• Ruiz-Malagon AJ, Rodriguez-Sanchez MJ, Rodriguez-Sojo MJ, Vezza T, Pischel I, Algieri F, Rodriguez-Cabezas ME, Rodriguez-Nogales A, Galvez J. Intestinal anti-inflammatory and visceral analgesic effects of a Serpylli herba extract in an experimental model of irritable bowel syndrome in rats. Front Pharmacol. 2022 Sep 2;13:967644. doi: 10.3389/fphar.2022.967644. eCollection 2022.

  PMID: 36120292 BACKGROUND

• Pavel M, Vostinaru O, Mogosan C, Ghibu S. Phytochemical and pharmacological research on some extracts obtained from Serpylli herba. Farmacia 2011;59:77-84.

  BACKGROUND

• Knaub, K., Schön, C., Suarez, C.G. and Pischel, I. (2022) Effects of a Food Supplement with a Wild Thyme (Thymus serpyllum L.) Extract on Gut Health and the Microbiome in Humans: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. Food and Nutrition Sciences, 2022;13:931-949.

  BACKGROUND

• Ruiz-Malagon AJ, Rodriguez-Sojo MJ, Hidalgo-Garcia L, Molina-Tijeras JA, Garcia F, Pischel I, Romero M, Duarte J, Diez-Echave P, Rodriguez-Cabezas ME, Rodriguez-Nogales A, Galvez J. The Antioxidant Activity of Thymus serpyllum Extract Protects against the Inflammatory State and Modulates Gut Dysbiosis in Diet-Induced Obesity in Mice. Antioxidants (Basel). 2022 May 28;11(6):1073. doi: 10.3390/antiox11061073.

  PMID: 35739969 BACKGROUND

• Jaric S, Mitrovic M, Pavlovic P. Review of Ethnobotanical, Phytochemical, and Pharmacological Study of Thymus serpyllum L. Evid Based Complement Alternat Med. 2015;2015:101978. doi: 10.1155/2015/101978. Epub 2015 Jul 22.

  PMID: 26265920 BACKGROUND

• Algieri F, Rodriguez-Nogales A, Garrido-Mesa N, Zorrilla P, Burkard N, Pischel I, Sievers H, Benedek B, Feistel B, Walbroel B, Rodriguez-Cabezas ME, Galvez J. Intestinal anti-inflammatory activity of the Serpylli herba extract in experimental models of rodent colitis. J Crohns Colitis. 2014 Aug;8(8):775-88. doi: 10.1016/j.crohns.2013.12.012. Epub 2014 Jan 8.

  PMID: 24411672 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

microcrystalline cellulose; thyme extract

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 15, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)