Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics

NCT06250413 | Not Yet Recruiting

• 1 other identifier: HUS/2231/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical trial, our aim is to assess the effect of auto-FMT (Fecal microbiome transplantation) on the intestinal microbiota, after a course of antibiotics. 30 healthy adults are recruited. All are given a five day course of amoxicillin-clavulanate. The subjects are double blinded and randomized to two groups. Group A is given autologous FMT (auto-FMT) on day 7 (two days after the end of the course of antibiotics) and Group B is given auto-FMT on day 28 (23 days after the end of the course of antibiotics).

Conditions

Microbial Colonization; Antibiotic Side Effect

Keywords

FMT; lyophilized; antibiotics

Outcome Measures

Primary Outcomes (2)

• Feasibility and safety; Number of participants with treatment-related adverse events such as; nausea, vomiting, signs of infection such as elevation of CRP after receiving the capsules, bloody stools

  The feasibility and safety of the transplantation process using lyophilized auto-FMT. All adverse events are reported, CRP is taken from all patients at the day of the transplant and 2 day after. The participants answer to weekly online questionaires including questions of any abdominal symptoms, defecation frequency, stool consistence, abdominal pain, nausea and other used medication weekly until 7 weeks.

  2 months

• Taxonomic restoration of the gut microbiome at day 27.

  Quantitative PCR will be used for quantitative microbiota profiling.

  1 month

Secondary Outcomes (3)

• The percentage of participants with restoration of intestinal microbiome.

  3 months

• Magnitude and duration of GI-symptoms

  3 months

• Impact of FMT given to placebo group on day 28 on gut microbiome on day 48

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

The participants will be given 4 capsules containing fecal matter (Capsule 1) after treatment with antibiotics on day 7. Intervention group will be given placebo (Capsules 2) on day 28.

Other: FMT; Other: Placebo; Drug: Amox Clav

Control

PLACEBO COMPARATOR

The participants will be given 4 placebo capsules (Capsule 2) after treatment with antibiotics on day 7. Control group will be given FMT capsules (Capsules 1) as "rescue therapy" on day 28.

Other: FMT; Other: Placebo; Drug: Amox Clav

Interventions

FMT OTHER

Capsulated oral auto fecal microbiota transplant

Control; Intervention

Placebo OTHER

Capsulated hot chocolate powder

Control; Intervention

Amox Clav DRUG

5 day course of Amoxicillin Clavulanic acid given to all participants

Also known as: Amorion comp

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• previously healthy

You may not qualify if:

• IBD (inflammatory bowel disease)
• celiac disease
• abdominal symptoms such as diarrhea or constipation necessitating medical therapy
• pregnancy and breastfeeding
• allergy towards antibiotics penicillins
• allergy towards soya.
• trehalose intolerance.
• travelling outside of European Union during the last 3 months
• use of antibiotics during the last 3 months
• use of probiotics during the previous 2 weeks or during the study.

Sponsors & Collaborators

• Otto Helve: lead
• University of Helsinki: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Location

Related Publications (5)

• Jernberg C, Lofmark S, Edlund C, Jansson JK. Long-term impacts of antibiotic exposure on the human intestinal microbiota. Microbiology (Reading). 2010 Nov;156(Pt 11):3216-3223. doi: 10.1099/mic.0.040618-0. Epub 2010 Aug 12.

  PMID: 20705661 BACKGROUND

• Reygner J, Charrueau C, Delannoy J, Mayeur C, Robert V, Cuinat C, Meylheuc T, Mauras A, Augustin J, Nicolis I, Modoux M, Joly F, Waligora-Dupriet AJ, Thomas M, Kapel N. Freeze-dried fecal samples are biologically active after long-lasting storage and suited to fecal microbiota transplantation in a preclinical murine model of Clostridioides difficile infection. Gut Microbes. 2020 Sep 2;11(5):1405-1422. doi: 10.1080/19490976.2020.1759489. Epub 2020 Jun 5.

  PMID: 32501140 BACKGROUND

• Suez J, Zmora N, Zilberman-Schapira G, Mor U, Dori-Bachash M, Bashiardes S, Zur M, Regev-Lehavi D, Ben-Zeev Brik R, Federici S, Horn M, Cohen Y, Moor AE, Zeevi D, Korem T, Kotler E, Harmelin A, Itzkovitz S, Maharshak N, Shibolet O, Pevsner-Fischer M, Shapiro H, Sharon I, Halpern Z, Segal E, Elinav E. Post-Antibiotic Gut Mucosal Microbiome Reconstitution Is Impaired by Probiotics and Improved by Autologous FMT. Cell. 2018 Sep 6;174(6):1406-1423.e16. doi: 10.1016/j.cell.2018.08.047.

  PMID: 30193113 RESULT

• Bulow C, Langdon A, Hink T, Wallace M, Reske KA, Patel S, Sun X, Seiler S, Jones S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Impact of Amoxicillin-Clavulanate followed by Autologous Fecal Microbiota Transplantation on Fecal Microbiome Structure and Metabolic Potential. mSphere. 2018 Nov 21;3(6):e00588-18. doi: 10.1128/mSphereDirect.00588-18.

  PMID: 30463925 RESULT

• Taur Y, Coyte K, Schluter J, Robilotti E, Figueroa C, Gjonbalaj M, Littmann ER, Ling L, Miller L, Gyaltshen Y, Fontana E, Morjaria S, Gyurkocza B, Perales MA, Castro-Malaspina H, Tamari R, Ponce D, Koehne G, Barker J, Jakubowski A, Papadopoulos E, Dahi P, Sauter C, Shaffer B, Young JW, Peled J, Meagher RC, Jenq RR, van den Brink MRM, Giralt SA, Pamer EG, Xavier JB. Reconstitution of the gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant. Sci Transl Med. 2018 Sep 26;10(460):eaap9489. doi: 10.1126/scitranslmed.aap9489.

  PMID: 30257956 RESULT

MeSH Terms

Conditions

Communicable Diseases

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Otto Helve, Docent

  University of Helsinki

  STUDY DIRECTOR

Central Study Contacts

Noora Carpén, MD

CONTACT

+358 9 4711; noora.carpen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Docent

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 9, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)