AzTrials
AzTrials

Severe Acute MalnutritionNCT06722404

Synbiotics for the Management of Malnutrition (Children)

A study testing Standard therapeutic foods and Therapeutic foods plus Synbiotics in people with Severe Acute Malnutrition, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.

Completed

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

Official record
Search all trials

Trial summary

In this study, dose related effect of synbiotics on the blood indices of severely acute malnourished (SAM) children (6-59 months) was carried out in hospitalized setting. Fifty SAM children were enrolled in a double-blind, randomized design. Read more about this study

Who is it for?
Ages 6 to 59 months
Conditions the study is for
Severe Acute Malnutrition
What is being tested?
Standard therapeutic foods and Therapeutic foods plus Synbiotics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePakistan
Study dates
7 Mar 2017to 19 Oct 2017
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 6 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • In the present study we enrolled 50 severely acute malnourished (SAM) patients of 6-59 months of age while follow-up treatment was given at the out-patient department.
  • Patients having weight-for-height of less than 70% of the median, nutritional edema (Kwashiorkor), or both,
  • mid-upper arm circumference (MUAC) of less than 11.5cm

Who cannot join

  • Participant taking other supplements or enrolled in other studies

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Nutrition Rehabilitation Unit (NRU), Department of Social & Preventive Pediatrics, Mayo Hospital,

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effect of Synbiotics on Hematological Indices of Malnourished Children

In this study, dose related effect of synbiotics on the blood indices of severely acute malnourished (SAM) children (6-59 months) was carried out in hospitalized setting. Fifty SAM children were enrolled in a double-blind, randomized design.

Read the detailed description

The study was done at Nutrition Rehabilitation Unit (NRU), Department of Social \& Preventive Pediatrics, Mayo Hospital, Lahore, Pakistan, a Tertiary Care large urban teaching and referral hospital and was approved by human ethics Institutional Review Board (IRB) .Galacto-oligosaccharides (Oligomate) as prebiotics were procured from Yakult Pharmaceutical Industry, Japan and Resiton (lactobacillus paracasei subsp. paracasei) as probiotics were procured from MakNsons Pharmaceutical Industry, Italy. In the present study we enrolled 50 severely acute malnourished (SAM) in patients of 6-59 months of age while follow-up treatment was given at the out-patient department. We define SAM as weight-for height of less than 70% of the median, nutritional edema (Kwashiorkor), or both, mid-upper arm circumference (MUAC) of less than 11.5cm. Anthropometry protocols were followed by research standards

Being tested
Standard therapeutic foods, Therapeutic foods plus Synbiotics
Medical subject headings
Severe Acute Malnutrition

What participants receive

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

  • Standard therapeutic foodsDietary supplement

    All children were initially fed F-75 (75 kcal/ 100mL) therapeutic milk (Phase I) and then progressed to F-100 (100 kcal/ 100mL) (Phase II) and Plumpy'nuts (F-100 in spread form with iron fortification) (Phase III) with follow-up for 48 days

  • Therapeutic foods plus SynbioticsCombination product

    the intervention group received therapeutic foods plus synbiotics containing Oligomate that was fortified in F75 at the rate of 7.5 g/L containing 4.1 g/L GOS for 1 g/100 kcal dose and at the rate of 11.5 g/L containing 6.1 g/L GOS for 1.5 g/100 kcal dose while in F100 and Plumpy'nuts it was fortified at the rate of 10 g/L containing 5.5 g/L GOS for 1 g/100 kcal dose and at the rate of 15 g/L containing 8.25 g/L GOS for 1.5 g/100 kcal dose and Resiton (Lactobacillus paracasei sbsp. paracasei) 3 billion cfu/day and 6 billion cfu/day that were mixed in different combinations.

Study groups in NCT06722404
Study groupRoleWhat they receive
standard therapeutic food groupActive comparatorThe control group received standard therapeutic foods (F-75, F-100 and Plumpy'nuts)
Receives: Dietary Supplement: Standard therapeutic foods
therapeutic foods plus synbiotics groupExperimentalthe intervention group received therapeutic foods plus synbiotics containing Oligomate that was fortified in F75 at the rate of 7.5 g/L containing 4.1 g/L GOS for 1 g/100 kcal dose and at the rate of 11.5 g/L containing 6.1 g/L GOS for 1.5 g/100 kcal dose while in F100 and Plumpy'nuts it was fortified at the rate of 10 g/L containing 5.5 g/L GOS for 1 g/100 kcal dose and at the rate of 15 g/L containing 8.25 g/L GOS for 1.5 g/100 kcal dose and Resiton (Lactobacillus paracasei sbsp. paracasei) 3 billion cfu/day and 6 billion cfu/day that were mixed in different combinations.
Receives: Combination Product: Therapeutic foods plus Synbiotics

What is being measured

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

  1. Weight

    weight change observed in patients

    Measured: 48 days

  2. Number of Stools

    Number of stools per day

    Measured: 48 days

Secondary outcomes (7)

  1. Complete blood count (CBC)

    For hematological and biochemical screening 5 mL venous blood was taken after 12 h fasting in vacutainers tubes containing ethylenediamine tetra-acetic acid (EDTA). Complete blood count (CBC) was carried out using haemocytometer

    Measured: 48 days

  2. Serum albumin levels

    The assay is based on the selective interaction between BCG and albumin forming a chromophore that can be detected at 620 nm using spectrophotometer. The signal is directly proportional to the amount of albumin present in the serum. BCG does not react with other abundant plasma proteins like IgG

    Measured: 48 days

  3. serum electrolytes

    Serum electrolytes such as Na and K were analyzed by electrolyte analyzer (Biolyte 2000; BioCare Corporation, Taiwan). Briefly, 10 mL blood was obtained from each subject and then blood samples were allowed to stand for 1 h to clot. Thereafter, blood samples were centrifuged at 300 rpm, 15 min at room temperature. The supernatant was then separated from the settled bottom blood cells

    Measured: 48 days

  4. ESR determination

    anti-coagulated blood was allowed to stand in a narrow vertical glass tube, undisturbed for a period of time, the RBCs under the influence of gravity settled out from the plasma. The rate at which they settled was measured as the number of millimeters of clear plasma present at the top of the column after one hour (mm/h).

    Measured: 48 days

  5. SGPT/ ALT

    ALT is an important indicator of liver disease. The series of reactions involved in the assay system is as follows; L-Alanine + 2- oxoglutarate → Pyruvate + L-Glutamate; Pyruvate + NADH → Lactate+ NAD. Then this rate of Nicotinamide adenine dinucleotide (NADH) consumption is determined photo metrically that is proportional to ALT activity in the sample.

    Measured: 48 days

  6. SGOT/ AST

    The AST is the cellular enzyme, is found in highest concentration in heart muscle, the cells of the liver and the cells of the skeletal muscle. The rate of decrease in concentration of NADH, measured photometrically at 340 nm is proportional to the catalytic concentration of AST present in the sample.

    Measured: 48 days

  7. Alkaline Phosphatase

    For the determination of alkaline phosphatase, the following protocol was adopted . Alkaline phosphatase release phenol from para nitrophenylphosphate, the phenol in alkaline medium gives yellow color which can be estimated with spectrophotometer at 405 nm. The reagents required for this experiment are R1=diethanolamine (pH 9.8, 1.2 mol/L), magnesium chloride (0.6 mmol/L); R2=p-nitrophenylphosphate (50 mmol/L).

    Measured: 48 days

Timeline

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

  1. First posted9 Dec 2024
  2. Study start7 Mar 2017
  3. Primary completion11 Aug 2017
  4. Study completion19 Oct 2017

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
All children were initially fed F-75 (75 kcal/ 100mL) therapeutic milk (Phase I) and then progressed to F-100 (100 kcal/ 100mL) (Phase II) and Plumpy'nuts (F-100 in spread form with iron fortification) (Phase III) with follow-up for 48 days. Synbiotics treatments were given from the onset of F-75 till the child progressed.The control group received standard therapeutic foods (F-75, F-100 and Plumpy'nuts), whereas the intervention group received therapeutic foods plus synbiotics containing Oligomate that was fortified in F75 at the rate of 7.5 g/L containing 4.1 g/L GOS for 1 g/100 kcal dose and at the rate of 11.5 g/L containing 6.1 g/L GOS for 1.5 g/100 kcal dose while in F100 and Plumpy'nuts it was fortified at the rate of 10 g/L containing 5.5 g/L GOS for 1 g/100 kcal dose
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06722404
Sponsor's protocol ID
BeSt 44/ 17
Other IDs
PIN No. 085-14090-AV5-176
Status last verified
Dec 2024
First submitted
3 Dec 2024
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: study data will be published in research journal without personal identity

Publications

  • Basu S, Chatterjee M, Ganguly S, Chandra PK. Effect of Lactobacillus rhamnosus GG in persistent diarrhea in Indian children: a randomized controlled trial. J Clin Gastroenterol. 2007 Sep;41(8):756-60. doi: 10.1097/01.mcg.0000248009.47526.ea.

    PubMed 17700424

Questions about this trial

What is this clinical trial studying?

A study testing Standard therapeutic foods and Therapeutic foods plus Synbiotics in people with Severe Acute Malnutrition, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.

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 3 inclusion and 1 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 9 Dec 2024. 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 Pakistan. 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. 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?

Weight (time frame: 48 days). The study lists 2 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 NCT06722404, which also lists 1 linked publication.

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 9 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in