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Overweight and ObesityNCT06213480

Next-Generation Synbiotic in Individuals With Overweight or Obesity

A study testing Synbiotic Group in people with Overweight and Obesity, run by Texas Christian University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Synbiotic Group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteUnited States
Study dates
2 Feb 2024to 20 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Christian University, Rickel Building

    Fort Worth, Texas, 76129

Other trials in United States

About this study

Official title: Supplementation With a Next-Generation Synbiotic in Individuals With Overweight or Obesity: A Triple-Blinded Randomized Controlled Clinical Trial

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.

Read the detailed description

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.

Being tested
Synbiotic Group, Placebo Group
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synbiotic GroupDietary supplement

    Also called The utilized synbiotic is Pendulum Glucose Control

    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)

  • Placebo GroupOther

    Also called Placebo

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

Study groups in NCT06213480
Study groupRoleWhat they receive
Synbiotic GroupExperimentalThey 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.
Receives: Dietary Supplement: Synbiotic Group
Placebo GroupPlacebo comparatorThey will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo.
Receives: Other: Placebo Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Body Fat Mass through DXA (percentage)

    We will measure body fat mass by using DXA analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  2. Total Body Fat Mass through BodPod (percentage)

    We will measure body fat mass by using BodPod analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  3. Fat Mass to Height (kg/m2)

    We will measure body fat mass by using DXA analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  4. Fat Mass (kg)

    We will measure body fat mass by using BodPod analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  5. Body Lean Mass to Height (kg/m2)

    We will measure body lean mass by using DXA analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  6. Fat Free Mass (%)

    We will measure body lean mass by using BodPod analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  7. Fat Free Mass (Kg)

    We will measure body lean mass by using BodPod analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  8. Visceral Fat Volume (cm3)

    We will measure body visceral mass by using DXA and BodPod analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  9. Visceral Fat Mass (grams)

    We will measure body visceral mass by using DXA and BodPod analysis.

    Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.

  10. Fasting Glucose (mg/dL)

    We will measure fasting glucose after a 12h fast.

    Measured: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.

  11. Fasting Insulin (mIU/L)

    We will measure fasting insulin after a 12h fast.

    Measured: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.

  12. HbA1c (%)

    We will measure HbA1c after a 12h fast.

    Measured: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.

  13. Anxiety (number in 0-63 scale)

    We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels.

    Measured: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.

  14. Depression (number in 0-63 scale)

    We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression.

    Measured: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.

  15. Food cravings (number in 0-52 scale)

    We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings.

    Measured: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.

  16. Gut Microbial Composition (depending on funding availability at the time of analysis)

    We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes.

    Measured: Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.

  17. Blood Microbial Composition (depending on funding availability at the time of analysis)

    We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes.

    Measured: Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.

  18. Body Weight (kg)

    Body weight will be measured with a calibrated scale.

    Measured: 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.

  19. Body Height (meters)

    Body height will be measured with a stadiometer.

    Measured: Measurement will take place at the first visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start2 Feb 2024
  3. Primary completion20 May 2025
  4. Study completion20 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sixty participants will be randomized into one of two groups: 1) 3-day antibiotic plus placebo for 3 months, or 2) 3-day antibiotic plus symbiotic for 3 months.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06213480
Sponsor's protocol ID
2023-345
Status last verified
Sep 2026
First submitted
20 Dec 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.

Publications

  • Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.

    PubMed 31263284

  • Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.

    PubMed 32675291

Questions about this trial

What is this clinical trial studying?

A study testing Synbiotic Group in people with Overweight and Obesity, run by Texas Christian University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Body Fat Mass through DXA (percentage) (time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06213480, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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