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Synbiotikum der nächsten Generation bei Personen mit Übergewicht oder Adipositas

28. September 2026 aktualisiert von: Elisa Marroquin, Texas Christian University

Ergänzung mit einem Synbiotikum der nächsten Generation bei Personen mit Übergewicht oder Adipositas: Eine dreifach verblindete, randomisierte, kontrollierte klinische Studie

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

75

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Texas
      • Fort Worth, Texas, Vereinigte Staaten, 76129
        • Texas Christian University, Rickel Building

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Nahrungsergänzungsmittel: 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)

Andere Namen:
  • Das verwendete Synbiotikum ist 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.
Sonstiges: 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).

Andere Namen:
  • Placebo

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total Body Fat Mass through DXA (percentage)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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 (%)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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 (%)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Measurement will take place at the first visit.

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Texas Christian University

Mitarbeiter

Pendulum Therapeutics

Ermittler

  • Hauptermittler: Elisa Marroquin, Ph.D., Texas Christian University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. Februar 2024

Primärer Abschluss (Tatsächlich)

20. Mai 2025

Studienabschluss (Tatsächlich)

20. Mai 2025

Studienanmeldedaten

Zuerst eingereicht

20. Dezember 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Januar 2024

Zuerst gepostet (Tatsächlich)

19. Januar 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2023-345

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

Not available at this point. Recruitment has not started.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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