Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420843
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
Microbiota Metabolome and Nutrition an Artificially Intelligent Way to Personalized Nutrition
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Microbiota Metabolome and Nutrition an Artificially Intelligent Way to Personalized Nutrition
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PN-AI-21
Brief Summary:
Intervention
Weeks 1-2 Visit 3-4 - Starting from the second week after the date of consent patients with IBS will be randomized 11 into two groups The first group 20 patients will receive one week of a low FODMAP supplemented with fermented milk followed by one week of a low FODMAP content supplemented with fermented beans The second group 20 patients will receive a low FODMAP diet supplemented for one week with fermented beans followed by a second week of a diet with a low FODMAP diet supplemented with fermented milk The microbiome of the patients will be evaluated after the first and second weeks along with data related to weight After the second week the metabolome and physical characteristics The enrollment period will last for one year The analysis of clinical data will be completed within one year after patient enrollment Analysis of laboratory data will be performed in parallel
Weeks 1-2 Visit 3-4 - Starting from the second week after the date of consent patients with IBS will be randomized 11 into two groups The first group 20 patients will receive one week of a low FODMAP supplemented with fermented milk followed by one week of a low FODMAP content supplemented with fermented beans The second group 20 patients will receive a low FODMAP diet supplemented for one week with fermented beans followed by a second week of a diet with a low FODMAP diet supplemented with fermented milk The microbiome of the patients will be evaluated after the first and second weeks along with data related to weight After the second week the metabolome and physical characteristics The enrollment period will last for one year The analysis of clinical data will be completed within one year after patient enrollment Analysis of laboratory data will be performed in parallel
Detailed Description:
Irritable bowel syndrome IBS is a chronic intestinal condition whose high incidence and prevalence make it a major healthcare problem3-7 IBS affects 7-15 of the general population6 7 It is twice as frequent in women8 and is diagnosed more often in patients less than 50 years of age9 It is characterized by recurrent episodes of functional gastrointestinal symptoms whose pathophysiological mechanisms are not completely clear10 The most common symptoms include abdominal pain bloating constipation andor diarrhea10 IBS negatively impacts quality of life and causes a substantial burden on healthcare resources11 12 Like the clinical phenotypes the pathophysiological mechanisms underlying the syndrome are heterogeneous and not fully understood13 However there is evidence that IBS may result from a combination of gastrointestinal motility changes visceral hypersensitivity low-grade inflammation altered microbiota and food components14-17 Due to the diversity of IBS symptoms and their considerable variability over time a wide range of pharmacological treatments are employed which often only target the primary symptom thus when multiple symptoms are present the treatments administered are often inadequate This has led to the investigation of use of dietary therapies as a treatment option
Dietary restriction of fermentable oligosaccharides disaccharides monosaccharides and polyols FODMAPs have been recently investigated in the management of functional gut symptoms in IBS An increasing number of uncontrolled and controlled trials have examined the clinical effectiveness of a low FODMAP diet in patients with IBS using either dietary advice or feeding protocols Uncontrolled and unblinded controlled trials suggest symptom response rates in patients with IBS are as high as 8518 Similarly a beneficial impact on symptoms has been reported in blinded randomized controlled trials19-22 A potential shortcoming of the low FODMAP diet and of any diet that involves multiple food exclusion is the risk of nutritional inadequacy and this is especially pertinent if the excluded foods are nutrient-rich The low FODMAP diet requires substitution of selected food items across a number of food groups and therefore there is the potential for inadequate intake of nutrients particularly carbohydrate fiber iron B vitamins and calcium Another potential safety concern associated with implementation of the diet relates to the impact on the gastrointestinal microbiota which has been implicated in the pathogenesis of IBS23 and has been associated with clinical features of IBS including abdominal pain anxiety and depression24 25 Hence we propose to evaluate the microbiome and metabolome in IBS patients to create datasets of integrated data through AI tools Furthermore we aim to determine the effects of a low FOODMAP diet based on fermented products on the microbiome and metabolome in IBS patients These evaluations will allow to assess patients nutrient deficiency and the general quality of life pre and post intervention among groups and to develop a personalized treatment that will increase the quality of life in IBS patients
The low FODMAPs diet is associated with limitations particularly due to the elimination of several food items which can cause worsening of the side effects due to significant alteration of the intestinal microbiota composition and an overall reduction of the nutritional status Although probiotics seem to have beneficial effects on improving this side effect their way of function is still relatively unknown Much remains to be answered as to which strains isare most effective across the broad spectrum of IBS patients and whether single or combination of strains work best This leads to the question of whether individual differences among IBS patients in terms of microbiome diversity could affect the efficacy of probiotics therapy Therefore with our approach we propose a reshaping of the host-microbiota interactions through personalized nutrition which could be a new therapeutic avenue for both disease control and prevention Specifically we believe that a diet supplemented with previously fermented food items will be beneficial for the patients condition This fermentation will be controlled and performed with Lactobacillus paracasei strain CNCM I-5220 Through the longitudinal study we will be able to evaluate their grade of the disorder at baseline one week of low FODMAP diet and the effect of the fermented food items on their microbiota and metabolome after one and two weeks Furthermore by adopting new efficacious treatment options it might be possible to decrease the high recurrence rate of IBS patients to the public health system improving patients quality of life and decreasing the costs for the National Sanitary System SSN
The primary objective will be to assess the enterotypes of IBS patient at baseline and to analyze how supplementation of fermented food modifies the microbiome and metabolome in IBS patients following a low FODMAP diet
As secondary objective we will compare the efficacy and safety of two different nutritional approaches on IBS symptoms
Dietary restriction of fermentable oligosaccharides disaccharides monosaccharides and polyols FODMAPs have been recently investigated in the management of functional gut symptoms in IBS An increasing number of uncontrolled and controlled trials have examined the clinical effectiveness of a low FODMAP diet in patients with IBS using either dietary advice or feeding protocols Uncontrolled and unblinded controlled trials suggest symptom response rates in patients with IBS are as high as 8518 Similarly a beneficial impact on symptoms has been reported in blinded randomized controlled trials19-22 A potential shortcoming of the low FODMAP diet and of any diet that involves multiple food exclusion is the risk of nutritional inadequacy and this is especially pertinent if the excluded foods are nutrient-rich The low FODMAP diet requires substitution of selected food items across a number of food groups and therefore there is the potential for inadequate intake of nutrients particularly carbohydrate fiber iron B vitamins and calcium Another potential safety concern associated with implementation of the diet relates to the impact on the gastrointestinal microbiota which has been implicated in the pathogenesis of IBS23 and has been associated with clinical features of IBS including abdominal pain anxiety and depression24 25 Hence we propose to evaluate the microbiome and metabolome in IBS patients to create datasets of integrated data through AI tools Furthermore we aim to determine the effects of a low FOODMAP diet based on fermented products on the microbiome and metabolome in IBS patients These evaluations will allow to assess patients nutrient deficiency and the general quality of life pre and post intervention among groups and to develop a personalized treatment that will increase the quality of life in IBS patients
The low FODMAPs diet is associated with limitations particularly due to the elimination of several food items which can cause worsening of the side effects due to significant alteration of the intestinal microbiota composition and an overall reduction of the nutritional status Although probiotics seem to have beneficial effects on improving this side effect their way of function is still relatively unknown Much remains to be answered as to which strains isare most effective across the broad spectrum of IBS patients and whether single or combination of strains work best This leads to the question of whether individual differences among IBS patients in terms of microbiome diversity could affect the efficacy of probiotics therapy Therefore with our approach we propose a reshaping of the host-microbiota interactions through personalized nutrition which could be a new therapeutic avenue for both disease control and prevention Specifically we believe that a diet supplemented with previously fermented food items will be beneficial for the patients condition This fermentation will be controlled and performed with Lactobacillus paracasei strain CNCM I-5220 Through the longitudinal study we will be able to evaluate their grade of the disorder at baseline one week of low FODMAP diet and the effect of the fermented food items on their microbiota and metabolome after one and two weeks Furthermore by adopting new efficacious treatment options it might be possible to decrease the high recurrence rate of IBS patients to the public health system improving patients quality of life and decreasing the costs for the National Sanitary System SSN
The primary objective will be to assess the enterotypes of IBS patient at baseline and to analyze how supplementation of fermented food modifies the microbiome and metabolome in IBS patients following a low FODMAP diet
As secondary objective we will compare the efficacy and safety of two different nutritional approaches on IBS symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None