The effect of a diet with low FODMAP (oligosaccharides, disaccharides, monosaccharides and fermentable polyols) in the diet of breastfeeding mothers on the treatment of infantile colic
Finding a way to improve colic in infants, increase the quality of life of families and reduce the additional cost of drugs, by modifying the diet of nursing mothers.
Design
Clinical trial, with two intervention groups and a control group, one blind strain, with a sample size of 110, using block randomization method with 4 blocks
Settings and conduct
In this study, the participants are divided into two groups. The first group (intervention) are mothers who will be under the low FODMAP diet and the second group (control) are mothers who will be under the normal diet during breastfeeding. Both groups will be followed up for two weeks, and the rate of improvement in the colic of their infants will be compared .
Blinding is one-way blinding because only the patients are not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include being a term baby; mother with at least middle school education; exclusive breastfeeding; at least 5 months of age; crying more than 3 hours a day for 3 to more than 3 days a week; not having underlying diseases. The criteria for not entering the study include incomplete completion of the questionnaire and failure to follow the diet correctly by the mother.
Intervention groups
Intervention group: It will include giving special diet for breastfeeding with low FODMAP for two weeks and then checking and comparing it with the control group.
Control group: including giving a special diet during breastfeeding for two weeks without changing its FODMAP content
Main outcome variables
The frequency and average time of breastfeeding of infants; average sleep; the number of times and average time of crying of infants; the number of times of abdominal bloating of infants during 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230224057517N1
Registration date:2023-04-18, 1402/01/29
Registration timing:prospective
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Reyhaneh Aghaziaraty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3880 3517
Email address
ziaratyreyhan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a diet with low FODMAP (oligosaccharides, disaccharides, monosaccharides and fermentable polyols) in the diet of breastfeeding mothers on the treatment of infantile colic
Public title
The effect of a diet with simple carbohydrates on the treatment of infantile colic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Term baby (38 to 42 weeks)
Mother with at least middle school education
Exclusive breastfeeding
Age less than 5 months at the time of study
Crying more than 3 hours a day for 3 to more than 3 days a week
Not suffering from underlying diseases (gastrointestinal tract, kidney, lung, etc.) and not suffering from congenital abnormalities
Average family income level
Exclusion criteria:
Non-completion or incomplete completion of the case registration sheet by the mother
Failure to follow the correct diet by the mother
Age
To 5 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
To assign people to two groups, a block randomization method with a block size of 4 will be used, and by using this method, concealment will be observed. In this method, each person is assigned a unique code.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in this study is one-way blind. In fact , the participants included in this study, despite knowing all the advantages and disadvantages of this study, as well as having full consent and knowledge of participating in this study, have been placed as our blinding groups and are not aware of the type of treatment and study.
Placebo
Not used
Assignment
Parallel
Other design features
The participants in this study are divided into two groups, one (intervention) and two (control) , and the first group receives only one type of intervention during the study. Both groups are subjected to the same conditions during the study and only the first group receives the intervention we are considering.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences، Basij sq.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-11-20, 1401/08/29
Ethics committee reference number
IR.ARAKMU.REC.1401.239
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Colic recovery status of infants in the Barr scale
Timepoint
The beginning of the study, the seventh day and the fourteenth day after the intervention
Intervention group: The intended intervention will include giving the special diet for breastfeeding with low FODMAP for two weeks to the target group and then checking and comparing it with the control group. The diet considered for mothers will be three main meals, one snack in the morning and one snack in the afternoon. The selection of the ingredients of the food consumed by the mother will be done according to the guidance of the FODMAP database of Monash University, and according to that, a diet plan will be prepared by the nutritionist and will be provided to the participants. It is necessary to mention that the diet recommended to each of the participants is completely diverse, selective and based on the common and widely used foods of families, and only their consumption amount will be variable; In other words, the participants are given the right to choose the type of meal according to their preferences during the day, and families are not required to pay additional fees to comply with their diet.
Category
Other
2
Description
Control group: It will include giving a special diet for breastfeeding for two weeks. The diet considered for mothers will be three main meals, one snack in the morning and one snack in the afternoon. The selection of the ingredients of the food consumed by the mother will be done according to the guidance of the FODMAP database of Monash University, and according to that, a diet plan will be prepared by the nutritionist and will be provided to the participants. It is necessary to mention that the diet recommended to each of the participants is completely diverse, selective and based on the common and widely used foods of families, and only their consumption amount will be variable; In other words, the participants are given the right to choose the type of meal according to their preferences during the day, and families are not required to pay additional fees to comply with their diet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Arak Hospital
Full name of responsible person
Sajjadi Nooshin
Street address
Amirkabir Hospital, Shahid Shiroudi St.
City
Arak
Province
Markazi
Postal code
3898132345
Phone
+98 86 3313 6055
Email
ho.amirkabir@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
8735610954
Phone
+98 86 3417 3532
Email
www.salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Reyhaneh Aghaziaraty
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Arak University of Medical Sciences, Basij sq.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
Email
www.reyhanehziaraty550@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Reyhaneh Aghaziaraty
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Arak University of Medical Sciences, Basij sq.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098863313147
Fax
Email
www.reyhanehziaraty550@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Reyhaneh Aghaziaraty
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Arak University of Medical Sciences, Basij sq.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
Email
www.reyhanehziaraty550@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available