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Næste generations synbiotika hos personer med overvægt eller fedme

28. september 2026 opdateret af: Elisa Marroquin, Texas Christian University

Supplering med et næste generations synbiotikum hos personer med overvægt eller fedme: et triple-blindet randomiseret kontrolleret klinisk forsøg

This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.

Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.

Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.

Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.

Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.

Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76129
        • Texas Christian University, Rickel Building

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • be between 18-50 years of age
  • have a BMI between 25.0-40.0

Exclusion Criteria:

  • are following a vegetarian, vegan, carnivore, or keto diet
  • currently taking metformin, GLP-1 agonists, insulin, or fiber
  • have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
  • pregnant, planning pregnancy during the study period, or lactating
  • have a history of inflammatory bowel disease, colon cancer, or chronic polyps
  • have been diagnosed with type 1 or type 2 diabetes
  • have active cancer
  • are currently participating in a weight loss intervention (dietetic or medication)
  • have used antibiotics, antifungals, or antivirals in the past 3 months
  • have had a history of recent (within 30 days) diarrhea illness
  • have a known allergy to any component of the study product
  • have had an acute inflammatory infection or inflammatory condition in the past 4 weeks
  • have had >10% weight variation in the past 6 months
  • have had any bariatric surgery

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Synbiotic Group

They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber.
Kosttilskud: Synbiotic Group

WBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions.

Probiotic Ingredients:

Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis

The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)

Andre navne:
  • Det anvendte synbiotikum er Pendulum Glucose Control
Placebo komparator: Placebo Group

They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo.
Andet: Placebo Group

Ingredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation).

Andre navne:
  • Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Body Fat Mass through DXA (percentage)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body fat mass by using DXA analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Total Body Fat Mass through BodPod (percentage)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body fat mass by using BodPod analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Mass to Height (kg/m2)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body fat mass by using DXA analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Mass (kg)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body fat mass by using BodPod analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Body Lean Mass to Height (kg/m2)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body lean mass by using DXA analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Free Mass (%)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body lean mass by using BodPod analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Free Mass (Kg)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body lean mass by using BodPod analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Visceral Fat Volume (cm3)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body visceral mass by using DXA and BodPod analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Visceral Fat Mass (grams)
Tidsramme: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

We will measure body visceral mass by using DXA and BodPod analysis.
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fasting Glucose (mg/dL)
Tidsramme: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.

We will measure fasting glucose after a 12h fast.
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Fasting Insulin (mIU/L)
Tidsramme: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.

We will measure fasting insulin after a 12h fast.
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
HbA1c (%)
Tidsramme: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.

We will measure HbA1c after a 12h fast.
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Anxiety (number in 0-63 scale)
Tidsramme: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.

We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels.
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
Depression (number in 0-63 scale)
Tidsramme: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.

We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression.
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
Food cravings (number in 0-52 scale)
Tidsramme: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.

We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings.
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
Gut Microbial Composition (depending on funding availability at the time of analysis)
Tidsramme: Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.

We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes.
Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
Blood Microbial Composition (depending on funding availability at the time of analysis)
Tidsramme: Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.

We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes.
Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
Body Weight (kg)
Tidsramme: Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.

Body weight will be measured with a calibrated scale.
Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Body Height (meters)
Tidsramme: Measurement will take place at the first visit.

Body height will be measured with a stadiometer.
Measurement will take place at the first visit.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Texas Christian University

Samarbejdspartnere

Pendulum Therapeutics

Efterforskere

  • Ledende efterforsker: Elisa Marroquin, Ph.D., Texas Christian University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. februar 2024

Primær færdiggørelse (Faktiske)

20. maj 2025

Studieafslutning (Faktiske)

20. maj 2025

Datoer for studieregistrering

Først indsendt

20. december 2023

Først indsendt, der opfyldte QC-kriterier

9. januar 2024

Først opslået (Faktiske)

19. januar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023-345

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.

IPD-delingstidsramme

Data will be available only after authors and co-authors have published the material of their interest.

IPD-delingsadgangskriterier

Not available at this point. Recruitment has not started.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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