Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618677
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-04-24
Brief Title:
Efficacy of a Low FODMAP Diet in IBS Children and Impact on Urinary and Faecal Metabolome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of a Low FODMAP Diet in IBS Children and Impact on Microbiota Urinary and Faecal Metabolome
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Irritable bowel syndrome IBS is a functional gastrointestinal disorder characterized by abdominal pain associated with defecation or changes in stool frequency or stool form
The low FODMAPs diet LFD is a relatively new approach in the management of IBS and focuses on limiting intake of poorly absorbed carbohydrates
FODMAPs are highly fermentable but poorly absorbed short-chain carbohydrates and polyols contained in a wide variety of foods FODMAPs include oligosaccharides fructans fructo-oligosaccharides FOS and galacto-oligosaccharides GOS disaccharides lactose monosaccharides fructose and polyols sorbitol mannitol maltitol xylitol polydextrose and isomalt
Many studies and meta-analysis in adults have shown that a low FODMAPs diet is effective in reducing IBS symptoms particularly bloating and abdominal pain On the other hand evidences in children are scarce
Previous studies in adults have demonstrated differences in urine metabolites between IBS patients receiving LFD compared to a high FODMAP diet HFD providing interesting hypotheses for pathophysiological mechanisms in IBS
Aim of this study is to evaluate the efficacy of a LFD on gastrointestinal symptoms in children with IBS Moreover the investigators will assess the impact of LFD vs a diet with a standard content of FODMAPs SFD on the fecal and urinary metabolomic profile of pediatric IBS patients
This is a single center prospective single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari
The trial includes four phases run-in low FODMAP diet wash out and standard FODMAP diet The run-in phase weeks 1-2 aim to assess basal symptoms while on habitual diet and only symptomatic children VASgt3 will progress to the dietetic intervention trial
Then patients will be randomized to low or standard FODMAP diet for 14 days then children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet
The low FODMAPs diet LFD is a relatively new approach in the management of IBS and focuses on limiting intake of poorly absorbed carbohydrates
FODMAPs are highly fermentable but poorly absorbed short-chain carbohydrates and polyols contained in a wide variety of foods FODMAPs include oligosaccharides fructans fructo-oligosaccharides FOS and galacto-oligosaccharides GOS disaccharides lactose monosaccharides fructose and polyols sorbitol mannitol maltitol xylitol polydextrose and isomalt
Many studies and meta-analysis in adults have shown that a low FODMAPs diet is effective in reducing IBS symptoms particularly bloating and abdominal pain On the other hand evidences in children are scarce
Previous studies in adults have demonstrated differences in urine metabolites between IBS patients receiving LFD compared to a high FODMAP diet HFD providing interesting hypotheses for pathophysiological mechanisms in IBS
Aim of this study is to evaluate the efficacy of a LFD on gastrointestinal symptoms in children with IBS Moreover the investigators will assess the impact of LFD vs a diet with a standard content of FODMAPs SFD on the fecal and urinary metabolomic profile of pediatric IBS patients
This is a single center prospective single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari
The trial includes four phases run-in low FODMAP diet wash out and standard FODMAP diet The run-in phase weeks 1-2 aim to assess basal symptoms while on habitual diet and only symptomatic children VASgt3 will progress to the dietetic intervention trial
Then patients will be randomized to low or standard FODMAP diet for 14 days then children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet
Detailed Description:
Single center prospective single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari Metabolomic analysis will be performed at Department of Soil Plant and Food Science University of Bari Aldo Moro
The study will include all consecutive patients diagnosed with IBS according to the Rome IV criteria at Giovanni XXII Childrens Hospital of Bari The Giovanni XXII Childrens Hospital of Bari is the tertiary referral center for the diagnosis and follow-up of gastrointestinal disorders in our region covering an estimated population of 1400000 children National Institute of Statistics-httpswwwistatit accessed on 1 January 2023 with more than 10000 children followed up in the gastrointestinal clinic
The trial includes four phases run-in low FODMAP diet wash out and standard FODMAP diet The run-in phase weeks 1-2 aim to assess basal symptoms while on habitual diet and only symptomatic children VASgt3 will progress to the dietetic intervention trial
Then patients will be randomized to low or standard FODMAP diet for 14 days then children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet The order of the dietetic regimens is established according a computer-generated randomization list
Fecal and urinary samples for analyzing metabolome will be collected before interventions and at the end of each dietetic regimen
The study adheres to the Declaration of Helsinki was approved by the institutional ethical committee All patients gave full written informed consent
Dietetic intervention An experienced dietician will design two different dietetic regimens SFD and LFD as a tailored personalized menu of 2 weeks duration with manual calculation of nutrients and kilocalories according child age and weight At enrollment the dietician will explain the diets in detail to the families who will be not aware of the content of FODMAP low vs standard Parents will be only advised that the purpose of the study is to Assess whether changing the amount of certain foods in the diet could affects symptoms of IBS and the concept of FODMAPs wont be never mentioned during the study Both menus will be normocaloric and balanced in macro- and micronutrients in relation to the age of the patient under study according to the main principles of the Mediterranean diet All menus comprise five meals during the day breakfast snack lunch snack and dinner Food options present in the menus will be agree between the dietician parents and children
The food intake will be recorded on a diary and the same dietician during follow-up visits checked dietary compliance A proper dietary adherence was defined if percentage of amount of food left was less than 10 and number of times non-compliant per week was less than 2
The study will include all consecutive patients diagnosed with IBS according to the Rome IV criteria at Giovanni XXII Childrens Hospital of Bari The Giovanni XXII Childrens Hospital of Bari is the tertiary referral center for the diagnosis and follow-up of gastrointestinal disorders in our region covering an estimated population of 1400000 children National Institute of Statistics-httpswwwistatit accessed on 1 January 2023 with more than 10000 children followed up in the gastrointestinal clinic
The trial includes four phases run-in low FODMAP diet wash out and standard FODMAP diet The run-in phase weeks 1-2 aim to assess basal symptoms while on habitual diet and only symptomatic children VASgt3 will progress to the dietetic intervention trial
Then patients will be randomized to low or standard FODMAP diet for 14 days then children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet The order of the dietetic regimens is established according a computer-generated randomization list
Fecal and urinary samples for analyzing metabolome will be collected before interventions and at the end of each dietetic regimen
The study adheres to the Declaration of Helsinki was approved by the institutional ethical committee All patients gave full written informed consent
Dietetic intervention An experienced dietician will design two different dietetic regimens SFD and LFD as a tailored personalized menu of 2 weeks duration with manual calculation of nutrients and kilocalories according child age and weight At enrollment the dietician will explain the diets in detail to the families who will be not aware of the content of FODMAP low vs standard Parents will be only advised that the purpose of the study is to Assess whether changing the amount of certain foods in the diet could affects symptoms of IBS and the concept of FODMAPs wont be never mentioned during the study Both menus will be normocaloric and balanced in macro- and micronutrients in relation to the age of the patient under study according to the main principles of the Mediterranean diet All menus comprise five meals during the day breakfast snack lunch snack and dinner Food options present in the menus will be agree between the dietician parents and children
The food intake will be recorded on a diary and the same dietician during follow-up visits checked dietary compliance A proper dietary adherence was defined if percentage of amount of food left was less than 10 and number of times non-compliant per week was less than 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None