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Investigating the Effectiveness of Synbiotic Supplements on Micronutrient Status after Sleeve Gastrectomy Surgery

Protocol summary

Study aim
Investigating the effectiveness of synbiotic supplements on micronutrient status, gastrointestinal function, metabolic markers including lipid and glucose profiles, weight loss indicators, and quality of life in patients who have undergone Sleeve Gastrectomy surgery.
Design
Phase 3 randomized controlled clinical trial with a parallel-group, double-blind design, conducted on 76 patients. The patients are randomly assigned into two groups using block randomization with the help of the RAND function in Excel.
Settings and conduct
The study, conducted at Shariati hospital in Tehran, will evaluate patients before the intervention, 3 months after starting, and 3 months after completion. Group assignments are randomized, and known only to the product distributor.
Participants/Inclusion and exclusion criteria
This study includes adults aged 18-65 with class 3 obesity or class 2 obesity with an obesity-related condition who have undergone Sleeve Gastrectomy within the past month and are willing to participate. Individuals with a history of nutritional deficiencies, irreversible effects from such deficiencies, or factors interfering with study outcomes will be excluded.
Intervention groups
Intervention: BioGen®, containing strains of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum, Streptococcus thermophilus, and Bifidobacterium longum (a total of 10⁹ CFU/sachet), combined with 4 grams of inulin every 12 hours for 3 months. Control: starch.
Main outcome variables
Micronutrients (including serum 25-hydroxy vitamin D, serum vitamin B12, serum Folate, total serum Calcium, serum Iron, TIBC, and Ferritin); gastrointestinal function (GIQLI questionnaire); lipid profile (total cholesterol, TG, LDL, and HDL); glycemic profile (FBS and HbA1C); weight loss indicators (%EWL and %TWL); and quality of life (SF-36 questionnaire).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241209063999N1
Registration date: 2025-03-15, 1403/12/25
Registration timing: registered_while_recruiting

Last update: 2025-03-15, 1403/12/25
Update count: 0
Registration date
2025-03-15, 1403/12/25
Registrant information
Name
Mohammadmahdi Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 6382
Email address
mm-abbasi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Synbiotic Supplements on Micronutrient Status after Sleeve Gastrectomy Surgery
Public title
Investigating the Effects of Synbiotic Supplements on Micronutrients after Sleeve Gastrectomy Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults (18 to 65 years old) who, according to NIH guidelines, have class 3 obesity or class 2 obesity with at least one obesity-related co-morbidity and have undergone SG surgery within the past month Willingness to adhere to supplement intake and follow-up programs
Exclusion criteria:
Pregnant or lactating women Patients consuming other probiotic/prebiotic supplements, taking antibiotics up to 10 days before the start of the intervention, or using medications that affect gut microbiota The presence of severe malabsorption syndromes unrelated to surgery (inflammatory bowel disease, celiac disease, etc.) Presence of previous nutritional deficiencies Presence of any gastrointestinal diseases Presence of surgical complications (such as fistula at the incision site, gastrointestinal bleeding, intestinal obstruction, etc.) Unable to comprehend the purpose of evaluations or the proposed treatment Patients who refuse to participate in the study until its completion
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are placed in blocks of 4 or 6 and assigned to either the intervention or control group using a computer-generated random sequence. The allocation of patients to each block is based on the following criteria: Gender (male/female) Age (under 40 years and over 40 years) Underlying conditions (diabetes)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in each block are randomly divided into two groups, and each is assigned a unique code. Only the individual responsible for distributing the drug/placebo has access to the codes identifying patients in the intervention/control groups. The drug and placebo are prepared in identical packages and consumed in the same manner. The clinical team, which has direct contact with the patients and evaluates the study outcomes, will not have access to the group assignment list. Researchers will not have access to the group codes until data collection is complete.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.TUMS.EMRI.REC.1403.178

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Serum 25-hydroxy vitamin D
Timepoint
Before the start of the intervention, and 3 and 6 months after the intervention begins.
Method of measurement
immunoassay

2

Description
Serum vitamin B12
Timepoint
Before the start of the intervention, and 3 and 6 months after the intervention begins.
Method of measurement
Electrochemiluminescence

3

Description
Serum Iron
Timepoint
Before the start of the intervention, and 3 and 6 months after the intervention begins.
Method of measurement
spectrophotometry

4

Description
TIBC (Total Iron-Binding Capacity)
Timepoint
Before the start of the intervention, and 3 and 6 months after the intervention begins.
Method of measurement
spectrophotometry

5

Description
serum Ferritin
Timepoint
Before the start of the intervention, and 3 and 6 months after the intervention begins.
Method of measurement
immunoassay

6

Description
serum Folate
Timepoint
Before the start of the intervention, and 3 and 6 months after the intervention begins.
Method of measurement
Radioimmunoassay

7

Description
Serum total Calcium
Timepoint
Before the start of the intervention, and 3 and 6 months after the intervention begins.
Method of measurement
colorimetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The synbiotic supplement BioGen®, manufactured by Tak Gene Zist, contains strains of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum, Streptococcus thermophilus, and Bifidobacterium longum (total 10⁹ CFU per sachet) along with 4 grams of inulin (IRC code 2922037751120054). It is administered every 12 hours for a duration of 3 months.
Category
Treatment - Drugs

2

Description
Control group: The placebo, identical in appearance and taste to the synbiotic supplement (contains starch in the same volume as the supplement).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shriati Hospital
Full name of responsible person
Mohammadmahdi Abbasi
Street address
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadmahdi Abbasi
Street address
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Grant name
Funding for the Obesity and Eating Habits Research Center
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadmahdi Abbasi
Position
Non-faculty Specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
Email
mm-abbasi@student.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadmahdi Abbasi
Position
Non-faculty Specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
Email
mm-abbasi@student.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadmahdi Abbasi
Position
Non-faculty Specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Dr. Shariati Educational, Research, and Treatment Center, North Kargar St., Jalal Al-Ahmad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8807 6382
Fax
Email
mm-abbasi@student.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic information and study outcomes, including plasma micronutrients and glucose and lipid profiles of the patients, will be published in an anonymized form.
When the data will become available and for how long
6 months after publication of the article.
To whom data/document is available
Anonymized data will be available to researchers for scientific research purposes.
Under which criteria data/document could be used
Anonymized data, with source citation, can be used for future study designs, meta-analysis, and review articles.
From where data/document is obtainable
Applicants can obtain this information by contacting via the following email or fax: Email: mm-abbasi@student.tums.ac.ir Fax: +982188633039 Mohammadmahdi Abbasi - Principal Investigator
What processes are involved for a request to access data/document
After correspondence, the request will be approved by the Research Council of the Obesity and Eating Habits Research Center, and the results will be communicated to the applicant via fax or email within 10-14 days.
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