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ObesityPhase 2NCT07593170

AKK Study in Improving Obesity and Metabolic Status in Children and Adolescents

A Phase 2 study testing AKK in people with Obesity and Obese Adolescents, run by Central South University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The problem of obesity among children and adolescents is becoming increasingly serious and may affect their health in adulthood. Researches have found that a type of probiotic in the intestinal tract - "Akkermansia muciniphila" (referred to as AKK), may help regulate metabolism and weight. Read more about this study

Who is it for?
Ages 7 to 18 years
What is being tested?
AKK
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
6 Jun 2026to 12 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age range: 7 years old to 18 years old (inclusive of boundary values), gender not restricted.
  • Primary obesity: According to the WS/T 586-2018 standard issued by the National Health Commission of China, or the internationally recognized CDC/WHO standard, diagnosed as obesity (if BMI ≥ the 95th percentile of children of the same age and gender).
  • The subjects and their legal guardians understand the research content, voluntarily participate and sign the written informed consent form (for guardians), and the informed consent form (for children aged 8 years and above).
  • Able to comply with the research protocol, complete all visits and sample collection.

Who cannot join

  • Have a definite endocrine disorder causing obesity (such as Cushing's syndrome, hypothyroidism), a genetic syndrome (such as Prader-Willi syndrome), or other known organic diseases.
  • Have a severe primary disease of the liver, kidney, cardiovascular system, respiratory system or hematopoietic system, etc.
  • Have used antibiotics, probiotics, prebiotics or synbiotic products within 3 months prior to screening.
  • Have a history of systemic use of glucocorticoids or other drugs that may affect weight and metabolism (such as metformin, systemic glucocorticoids, diuretics, etc.) within 1 month prior to screening.
  • Subjects are allergic to any component of the study product (AKK probiotic capsules or placebo).
  • Subjects are participating in other clinical trials.
  • Have a history of severe gastrointestinal diseases, such as inflammatory bowel disease (IBD).
  • Other conditions as determined by the researcher to be unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qian Lin, Doctor contact

+86 13874820173

linqian@csu.edu.cn

China1 site
  • Xiangya School of Public Health

    Changsha, Hunan

    Qian Lin, Doctor, +86 13874820173, linqian@csu.edu.cn

    Chuxin Wang, Bachelor, +86 15367802575, 45100409@qq.com

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of Akkermansia Muciniphila AKK PROBIO in Improving Obesity and Metabolic Abnormalities in Children and Adolescents Aged 7-18 Years

The problem of obesity among children and adolescents is becoming increasingly serious and may affect their health in adulthood. Researches have found that a type of probiotic in the intestinal tract - "Akkermansia muciniphila" (referred to as AKK), may help regulate metabolism and weight. Although it has shown effects in adults, its safety and efficacy in children and adolescents still need further verification.

This study aims to evaluate the effects of supplementing Akkermansia Muciniphila AKK PROBIO on weight, metabolic health and intestinal flora of obese children and adolescents aged 7 to 18.

Read the detailed description

This study aims to evaluate the improvement effect of continuous supplementation with pasteurized inactivated Akkermansia muciniphila (AKK PROBIO) for 12 weeks on the body mass index z-score of obese children and adolescents aged 7 to 18 years, and systematically explore its impact on metabolic health indicators, anthropometric indicators, and sleep, as well as to clarify the safety and tolerance of this intervention. Through the integrated analysis of metagenomics and non-targeted metabolomics, the potential mechanism by which AKK PROBIO regulate the intestinal microbiota and host metabolic profiles in children and adolescents is revealed, providing a scientific basis and biomarker support for the development of precision nutrition intervention strategies for childhood and adolescent obesity.

Being tested
AKK, Placebo (maltodextrin)
Keywords
obesity, Akkermansia muciniphila
Medical subject headings
Obesity

What participants receive

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

  • AKKBiological

    This intervention trial intends to use pasteurized AKK PROBIO, with each dose containing the equivalent of 30 billion inactivated bacterial cells. AKK PROBIO is a research hotspot in the field of intestinal microecology. The pasteurized AKK PROBIO (belonging to prebiotics) have been proven to have good safety and metabolic improvement effects in adults. Compared to live bacterial preparations, the inactivated form has higher stability, a longer shelf life, and better safety. AKK group (n=50): The subjects take one AKK probiotic capsule orally before each breakfast and dinner every day, and the intervention lasted for 12 weeks. During the study period, both groups of participants will receive unified and standardized health education, which includes the principles of balanced diet provided by registered dietitians and the suggestions for physical activities provided by exercise rehabilitation specialists.

  • Placebo (maltodextrin)Drug

    Placebo group (n=50): The subjects took one placebo capsule (containing inert ingredients such as maltodextrin) identical in appearance and taste to the AKK probiotic capsules before each breakfast and dinner every day for 12 consecutive weeks. After the study ended, the subjects in the placebo group could receive the same dose and specification of AKK probiotic capsules.

Study groups in NCT07593170
Study groupRoleWhat they receive
AKK GroupExperimentalThis intervention trial intends to use pasteurized AKK PROBIO, with each dose containing the equivalent of 30 billion inactivated bacterial cells. AKK PROBIO is a research hotspot in the field of intestinal microecology. The pasteurized AKK PROBIO (belonging to prebiotics) have been proven to have good safety and metabolic improvement effects in adults. Compared to live bacterial preparations, the inactivated form has higher stability, a longer shelf life, and better safety. AKK group (n=50): The subjects take one AKK probiotic capsule orally before each breakfast and dinner every day, and the intervention lasted for 12 weeks. During the study period, both groups of participants will receive unified and standardized health education, which includes the principles of balanced diet provided by registered dietitians and the suggestions for physical activities provided by exercise rehabilitation specialists.
Receives: Biological: AKK
Placebo GroupPlacebo comparatorPlacebo group (n=50): The subjects took one placebo capsule (containing inert ingredients such as maltodextrin) identical in appearance and taste to the AKK probiotic capsules before each breakfast and dinner every day for 12 consecutive weeks. After the study ended, the subjects in the placebo group could receive the same dose and specification of AKK probiotic capsules. Basic intervention: During the study period, both groups of subjects would receive unified and standardized health education, including the principles of balanced diet provided by registered dietitians and the physical activity suggestions provided by exercise rehabilitation specialists.
Receives: Drug: Placebo (maltodextrin)

What is being measured

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

  1. Z - score

    The Z-score for children (Z-score) is a statistical indicator that measures the deviation of children's growth indicators such as height (in meters), weight (in kilograms), and BMI (in kg/m^2) from the reference population of the same age and gender. It is used to assess nutritional status and growth development levels.

    The nutritional status can be judged by evaluating the height-for-age z-score (HAZ), weight-for-age Z-score (WAZ), and weight-for-height z-score (WHZ) of children and BMI-for-age Z-score (BMIZ).

    The Z-score formula is: Z = (Measured value - Average value of the reference population) / Standard deviation of the reference population.

    Standard: ±2 : Normal range (95% healthy children)

    • -2 ≤ Z < -1: Less than Normal
    • Z < -2: Growth retardation, low weight or emaciation (<-3 is severe)
    • +1 ≤ Z ≤ +2: Overweight
    • +2 ≤ Z ≤ +3: Obesity
    • Z > +3: Severe obesity

    Measured: During the baseline period (T0), the middle period (T1, 6 weeks), and the end of the intervention (T2, 12weeks)

Secondary outcomes (5)
  1. Dietary intake

    The dietary intake of the research subjects was understood through 24-hour recall and food frequency questionnaires (for the past month). The dietary and nutrient intake of the research subjects was evaluated through food diversity scores and the intake of energy and nutrients(converts the weekly intake volume (ml/g) into "servings per week").

    A designed dietary frequency questionnaire was used to evaluate the regular and environmental dietary behaviors of adolescents in the past three months. The questionnaire is based on common dimensions of dietary behavior and mainly covers five core behavioral categories: having breakfast, having a late-night snack, having meals at school, eating alone, and using food delivery platforms. The frequency options for each category are "Never", "once a month or less", "2 to 3 times a month", "once a week", "2 to 3 times a week", "4 to 5 times a week", "once a day", "twice a day", and "three or more times a day".

    Measured: At the baseline (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

  2. Sleep quality (13- 18 years)

    The Pittsburgh Sleep Quality Index (PSQI) in Chinese was used to assess the subjective sleep quality of participants aged 13 to 18 years. This scale consists of 19 self-rated items and 5 other-rated items, and the scoring can yield 7 scoring items including sleep latency, sleep disorders, sleep quality, sleep duration, hypnotic drugs, sleep efficiency and daytime function.

    Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.

    The evaluation of different dimensions of the scale will be separately described.

    Measured: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

  3. Sleep quality (7- 12 years)

    For children aged 7 to 12 years, the sleep questionnaire items were designed based on the CSHQ (Children's Sleep Habits Questionnaire). It consists of 48 items (33 scoring items), and can assess specific sleep problems in eight aspects: poor sleep habits, sleep anxiety, irregular sleep duration, sleep breathing disorders, abnormal sleep patterns, daytime sleepiness, night awakenings, and prolonged sleep latency.

    CSHQ requires parents to recall their child's sleep patterns over the past 4 weeks, and to select the sleep condition that best represents the typical week for a 3-point Likert scale rating of "often" (5-7 times per week), "sometimes" (2-4 times per week), and "rarely" (0-1 time per week).

    Measured: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

  4. Gastrointestinal symptoms

    Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS).

    The GSRS is a specific scale consisting of 15 items , with each item scored from 1 (no symptoms at all) to 7 (extremely severe symptoms). The GSRS was used to assess the occurrence of gastrointestinal symptoms in the subjects over the past week, covering five types of digestive tract symptoms: reflux syndrome, abdominal pain syndrome, dyspepsia, diarrhea syndrome, and constipation syndrome. The total score is the sum of all items, with a higher score indicating a more severe condition.

    Measured: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

  5. Stool Classification

    The Bristol Stool Classification Scale (BSFS) was used to evaluate the type of stool. The BSFS is a widely used scale for assessing intestinal motility and can be used to understand the type of stool of the subjects over the past week. This scale presents the transformation from hard stool to watery stool through pictures of types one to seven.

    The seven types of stool are:

    Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)

    Measured: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

Timeline

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

  1. First posted18 May 2026
  2. Study start6 Jun 2026 (estimated)
  3. Primary completion20 Dec 2026 (estimated)
  4. Study completion12 Feb 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants were randomly assigned in a 1:1 ratio to the intervention group or the placebo group using computer-generated random sequences. Stratified block randomization was used, with stratification factors including age group (7-11 years vs. 12-18 years) and gender, to ensure balanced sample sizes in both groups throughout the trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07593170
Sponsor's protocol ID
HCHLL2026153
Status last verified
Jun 2026
First submitted
22 Apr 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AKK in people with Obesity and Obese Adolescents, run by Central South University at 1 site in China.

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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Jun 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 China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Qian Lin, Doctor (+86 13874820173, linqian@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Z - score (time frame: During the baseline period (T0), the middle period (T1, 6 weeks), and the end of the intervention (T2, 12weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Jun 2026.

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