Effectiveness of Bacillus Spore Probiotics in Reducing Constipation, Anorexia, and Slow Weight Gain in Children

NCT06154525 | Completed DMC

• 1 other identifier: TNLS 2023.1224/QLKH-VDD
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

Constipation is rising globally and is a health concern in Asia. Prolonged constipation, without proper care, can lead to complications affecting a child's physical and psychological development, causing significant health and socioeconomic impacts. Anorexia is also common in children, affecting their nutrient absorption, weight gain, and height development. Anorexic children are 2.5-3 times more likely to suffer from underweight and stunting. A number of studies have suggested that probiotics can reduce stool retention time and improve stool consistency, making them a natural and safe option for relieving constipation in adults and children. Probiotics, particularly spore-forming probiotics like Bacillus clausii, Bacillus subtilis, and Bacillus coagulans, have shown promise in improving gut health and combating anorexia, constipation, and malnutrition. With this background, the investigators conduct a research project titled "Evaluating the effectiveness of the LiveSpo® Preg-Mom and LiveSpo® KIDS in supporting the reduction of constipation, anorexia, and slow weight gain in children aged 24-60 months". The study aims to: (i) Evaluate the effectiveness of LiveSpo® Preg-Mom and LiveSpo® KIDS in reducing constipation, anorexia, and slow weight gain in children. (ii) Assessing the impact of probiotic supplementation on pro-inflammatory/anti-inflammatory cytokines concentrations in the blood, IgA concentrations in stools, and changes in the intestinal microbiota composition in the children's stools. Study Population: The sample size for aims is 201. Description of Sites: the study is conducted at three communes in Vo Nhai district, Thai Nguyen province. Description of Study Intervention: 201 eligible children aged 24-60 months with signs of anorexia, constipation, and meeting nutritional criteria were selected. The selected children are randomly assigned to three experiment groups, with 67 children per group. Blood samples are taken (at the start and after 28 days of intervention), and fecal samples are collected at the beginning of the study day, day 7, and day 28 of intervention, to analyze cytokine, IgA concentrations, and the gut microbiota. The intervention products are labeled with three codes corresponding to the three experiment groups (For example AA code is used for LiveSpo® Preg-Mom, BB code for LiveSpo® KIDS, CC for code for RO water) and these codes can be interchanged as needed. Study duration: 12 months

Conditions

Constipation; Anorexia; Weight Gain

Keywords

Bacillus spore; Children; Gut microbiota; Cytokine

Outcome Measures

Primary Outcomes (4)

• Changes in the frequency of bowel movements per week

  Changes in the frequency of bowel movements per week (times/week)

  Day 7 compared to Day 0 and Day 28 compared to Day 0

• Changes in the type of stool based on the Bristol Stool Scale

  Changes in the type of stool based on the Bristol Stool Scale 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)

  Day 7 compared to Day 0 and Day 28 compared to Day 0

• Changes in the average eating time per meal

  Changes in the average eating time per meal (minutes/meal)

  Day 7 compared to Day 0 and Day 28 compared to Day 0

• Changes in the weight

  Changes in the weight (kg)

  Day 7 compared to Day 0 and Day 28 compared to Day 0

Secondary Outcomes (4)

• Changes in cytokines levels of blood samples

  Day 28 compared to Day 0

• Changes in IgA levels in stool samples

  Day 7 compared to Day 0 and Day 28 compared to Day 0

• Changes in Intestinal microbiota

  Day 28 compared to Day 0

• Changes ratio between the type of bacteria Gr (+), and Gr (-)

  Day 7 compared to Day 0 and Day 28 compared to Day 0

Study Arms (3)

Control Group (CC)

PLACEBO COMPARATOR

The control group receives RO water with a dosage of 1 ampoule per time, 2 times per day for 28 days.

Other: RO water

Preg-Mom Group (AA)

EXPERIMENTAL

The Preg-Mom group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU/5 mL (LiveSpo® Preg-Mom) with a dosage of 1 ampoule per time, 2 times per day for 28 days.

Dietary Supplement: LiveSpo Preg-Mom

KIDS Group (BB)

EXPERIMENTAL

The KIDS group receives RO water plus B. subtilis and B. clausii at 3 billion CFU/5 mL (LiveSpo® KIDS) with a dosage of 1 ampoule per time, 2 times per day for 28 days.

Dietary Supplement: LiveSpo KIDS

Interventions

RO water OTHER

Aquafina's reverse osmosis (RO) water, produced by PepsiCo, have both obtained ISO 9001:2015 and ISO 22000:2018 certifications, which are internationally recognized standards for quality management and food safety management systems, respectively. The RO water ampoules are produced using a similar process as the LIVESPO Preg-Mom/ KIDS but contain 5ml of high-quality RO water from Aquafina (proper noun)

Control Group (CC)

LiveSpo Preg-Mom DIETARY_SUPPLEMENT

LiveSpo® Preg-Mom has a registration number 7695/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.

Preg-Mom Group (AA)

LiveSpo KIDS DIETARY_SUPPLEMENT

LiveSpo® KIDS has a registration number 1537/2023/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.

KIDS Group (BB)

Eligibility Criteria

• Age: 24 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 24-60 months.
• Children diagnosed with loss of appetite and/or constipation and/or diarrhea.
• Have a weight-for-age Z-score between -1 and -3.
• Children are fed via the digestive system and have been weaned from breastfeeding.
• The child's parent or guardian agrees to participate in the research and must provide a voluntary commitment letter to comply with the research requirements.

You may not qualify if:

• Children outside the age range of 24-60 months
• Severely malnourished children with WAZ-Score \> 3, HAZ-Score \> 3.
• Currently suffering from acute infectious diseases such as pneumonia, acute diarrhea, liver or kidney disorders, etc.
• Children with a history of preterm birth, low birth weight \< 2,500 grams, and twin-twin transfusion syndrome.
• Afflicted with chronic conditions or congenital disabilities, such as Crohn's disease or celiac disease.
• Children using laxatives or other probiotic supplements before the intended research or simultaneously using other probiotics during the research period.
• Parents or guardians who do not consent to participate in the research or do not comply with the research procedures

Sponsors & Collaborators

• Anabio R&D: lead
• National Institute of Nutrition, Vietnam: collaborator

Study Sites (1)

National Institute of Nutrition

Hanoi, 100000, Vietnam

Location

Related Publications (6)

• Levy EI, Lemmens R, Vandenplas Y, Devreker T. Functional constipation in children: challenges and solutions. Pediatric Health Med Ther. 2017 Mar 9;8:19-27. doi: 10.2147/PHMT.S110940. eCollection 2017.

  PMID: 29388621 BACKGROUND

• Chang CW, Chen MJ, Shih SC, Chang CW, Chiau JC, Lee HC, Lin YS, Lin WC, Wang HY. Bacillus coagulans (PROBACI) in treating constipation-dominant functional bowel disorders. Medicine (Baltimore). 2020 May;99(19):e20098. doi: 10.1097/MD.0000000000020098.

  PMID: 32384482 BACKGROUND

• Dong M, Wu Y, Zhang M, Chen P, Zhang Z, Wang S. Effect of probiotics intake on constipation in children: an umbrella review. Front Nutr. 2023 Sep 1;10:1218909. doi: 10.3389/fnut.2023.1218909. eCollection 2023.

  PMID: 37720380 BACKGROUND

• Freedman KE, Hill JL, Wei Y, Vazquez AR, Grubb DS, Trotter RE, Wrigley SD, Johnson SA, Foster MT, Weir TL. Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis DE111. Int J Mol Sci. 2021 Feb 28;22(5):2453. doi: 10.3390/ijms22052453.

  PMID: 33671071 BACKGROUND

• Huang R, Hu J. Positive Effect of Probiotics on Constipation in Children: A Systematic Review and Meta-Analysis of Six Randomized Controlled Trials. Front Cell Infect Microbiol. 2017 Apr 28;7:153. doi: 10.3389/fcimb.2017.00153. eCollection 2017.

  PMID: 28503492 BACKGROUND

• Bekkali NL, Bongers ME, Van den Berg MM, Liem O, Benninga MA. The role of a probiotics mixture in the treatment of childhood constipation: a pilot study. Nutr J. 2007 Aug 4;6:17. doi: 10.1186/1475-2891-6-17.

  PMID: 17683583 BACKGROUND

Related Links

• UNICEF/WHO/The World Bank. 2021. Levels and trends in child malnutrition. World Health Organization. ISBN: 9789240025257

MeSH Terms

Conditions

Constipation; Anorexia; Weight Gain

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Study Officials

• Hanh TL Nguyen, PhD

  National Institute of Nutrition (NIN), Ministry of Health, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: LiveSpo Preg - Mom, LiveSpo KIDS, and RO water are indistinguishable regarding smell and taste. Because the three liquid products are packed in opaque plastic ampoules, the color and turbidity of the suspension are unrecognizable to investigators, trainers, the patient's parents, and patients except for the Principal Investigator (PI) and final data analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, controlled clinical trial

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 4, 2023
• Study Start: March 10, 2024
• Primary Completion: April 7, 2024
• Study Completion: September 30, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data requests can be submitted 9 months after article publication and will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. It will be provided following the review and approval of a study protocol, informed consent form (ICF), and clinical study report (CSR). For more information or to submit a request, please get in touch with clinicaltrial.probiotics@gmail.com

Locations

VN (1)