human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background . There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants . Methods . A r and omized , controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic . In the active arm , mothers excluded cow 's milk , eggs , peanuts , tree nuts , wheat , soy , and fish from their diet ; mothers in the control group continued to consume these foods . Outcomes were assessed after 7 days , as the change in cry/fuss duration over 48 hours , with vali date d charts . The primary end point was a reduction in cry/fuss duration of ≥25 % from baseline . Mothers also assessed the responses to diet with categorical and visual analog scales . Results . Of 107 infants , 90 completed the trial ( mean age : 5.7 weeks ; range : 2.9–8.6 weeks ; 54 male infants ) . Infants in both groups presented with significant distress ( geometric mean : low-allergen group : 690 minutes per 48 hours ; control group : 631 minutes per 48 hours ) . In follow-up assessment s on days 8 and 9 , there were significantly more responders in the low-allergen group ( 74 % vs 37 % ) , ie , an absolute risk reduction of 37 % ( 95 % confidence interval : 18–56 % ) . Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group ; the adjusted geometric mean ratio was 0.79 ( 95 % confidence interval : 0.63–0.97 ) , ie , an average reduction of 21 % ( 95 % confidence interval : 3–37 % ) . Mothers ' subjective assessment s of the responses to diet indicated little difference between the groups . Conclusion . Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life Because infants with colic appear to have  abdominal pain  similar to that of adults with irritable bowel syndrome , who may benefit from the addition of fiber to their diet , we tested whether fiber added to infant formula would alleviate colic .  Twenty-seven normal , term infants ( aged 2 to 8 weeks ; 14 girls ) with colic , defined as crying plus fussing for more than 3 hours a day for at least 3 days of a 6-day baseline period , were enrolled . Infants were r and omly assigned in 9-day periods to a sequence of placebo ( Isomil formula ) followed by fiber-supplemented formula ( Isomil plus soy polysaccharide ) ( n = 12 ) or the reverse ( n = 15 ) . Daily diaries of crying , fussing , sleeping , formula , intake , and stooling were kept . Twenty-two infants completed three lactulose breath hydrogen tests at the end of the baseline period and after each study period . The crossover trial was followed by 30 to 35 days of use of the study formula chosen by the parents as most beneficial but unknown to the investigators . Growth was monitored throughout . Serum cholesterol , calcium , phosphate , albumin , iron , and zinc concentrations were measured at the conclusion . There were no significant differences in average daily time spent by the infants in fussing and crying during ingestion of the fiber-supplemented formula . However , parents of 18 of 27 infants chose fiber-supplemented formula as most beneficial in ameliorating symptoms of colic . While the infants were consuming fiber-supplemented formula , stool frequency increased , and breath hydrogen excretion increased significantly , in response to lactulose . Growth and serum biochemical measurements were normal in all infants . Supplementation of infant formula with the level of soy polysaccharide used in this study may have reduced crying and fussing in some infants but did not affect colicky behavior in the majority of infants , who continued to cry and fuss excessively AIM AND OBJECTIVE The aim of the study was to evaluate the effectiveness of massage , sucrose solution , herbal tea or hydrolysed formula , each used individually in the treatment of infantile colic . BACKGROUND The term colic describes a group of symptoms that occur frequently in infants , consisting of paroxysmal abdominal pain and severe crying . Infant colic is of importance for both parents and the community health services that provide families with care , and is therefore an important clinical problem that is amenable to nursing interventions . DESIGN This prospect i ve and r and omised-controlled study involved 175 infants in Turkey . METHODS Data were gathered by using Wessel criteria ; parents wrote a daily structured diary , recording the onset and duration of crying . Patients were assigned r and omly into four different intervention groups ( massage , sucrose solution , herbal tea and hydrolysed formula ) and control group .  Duration of crying following each intervention was recorded in the diary by parents for a one week period . RESULTS There was a significant reduction in crying hours per day in all intervention groups . The difference between mean duration of total crying ( hours/day ) before and after the intervention infants in hydrolysed formula group was found higher than massage , sucrose and herbal tea group . The difference between mean duration of total crying(hours/day ) before and after the intervention infants in massage group was found lower than other intervention groups and all groups . CONCLUSION Our findings demonstrated that varied interventions such as administration of massage , sucrose solution , herbal tea and hydrolysed formula are effective in the treatment of colic . The difference between mean duration of total crying ( hours/day ) before and after the intervention in hydrolysed formula group was found higher than other intervention groups . Hydrolysed formula was the most effective in reducing the duration of crying ( hours/day ) when compared with the other intervention groups . Massage intervention yielded the least symptomatic improvement among all the interventions . RELEVANCE TO CLINICAL PRACTICE Colic treatment models used in this study can be used by nurses in neonatal and primary healthcare setting s as an aid to families for the treatment of infantile colic We evaluated the effect of an herbal tea preparation on  infantile colic  in a prospect i ve double-blind study . The use of tea eliminated the colic in 19 ( 57 % ) of 33 infants , whereas placebo was helpful in only 9 ( 26 % ) of 35 ( p < 0.01 ) . The mean colic score was significantly improved in tea-treated infants . No significant differences were noted between groups regarding number of night wakings The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change This study investigated the effect of changing the formulas of colicky infants and addressed the method ologic flaws of earlier studies . Attention was paid to issues of design ing a blind study , providing a washout period , and measuring and reproducing the effect . In this r and omized , double-blind trial , three changes of formula were made : for each of four 4-day periods , colicky infants alternately received a casein hydrolysate formula ( Nutramigen ) and a formula containing cow milk . Mothers recorded crying in diaries and indicated which crying episodes they considered to have been caused by colic . Nine infants were started on Nutramigen and eight on the cow milk formula .  With the first formula change there was significantly less crying and colic in infants when they were fed Nutramigen than when they were fed cow milk ( p less than 0.01 ) ; with the second change there was less colic when infants were fed Nutramigen ( p less than 0.05 ) but not significantly less crying . By the third change there were no significant differences between formulas . Further analyses demonstrated that there were more clinical ly meaningful positive responses ( a change in crying by at least one third ) to Nutramigen than to cow milk ( p less than 0.05 ) . However , only one subject had a clinical ly meaningful response in colic to all three formula changes . These results demonstrate that in some instances , colic improves with elimination of cow milk formula . However , the effect diminishes with time , and only infrequently is the effect reproducible This study examined 120 infants , aged 3–12 weeks , with severe colics and compared the results of a specific hypoallergenic diet ( group A ) with those of pharmacological treatment ( group B ) . Non‐breastfed group A infants  received soy milk and if unresponsive , hydrolyzed milk formulas ;  mothers of breast‐fed infants  received a diet without cow 's milk , eggs or fish .  Breast‐fed and non‐breast‐fed group B infants received dicyclomine hydrochloride 3 mg/kg/day . Results , based on quantitative measurements of crying . indicated that in breast‐fed infants there was no significant improvement between group A ( 62.5 % ) and group B ( 66.6 % ) infants . Among formula‐fed infants , comparison of positive results using soy milk ( 65.9 % ) with positive results using dicyclomine ( 53.3 % ) was not significant ; positive results using soy milk and hydrolyzed milk formulas in non‐responders to soy milk , provided an improvement in 95.4 % of cases . Pharmacological treatment provided an improvement in 53.3 % ) of cases . The diffcrence was significant ( p<0.01 ) Objectives : The aim of this study was to evaluate the efficacy on crying episodes owing to infantile colic of a new infant formula containing partially hydrolysed whey proteins , prebiotic oligosaccharides ( OS ) , with a high β-palmitic acid content . Design : Prospect i ve r and omized controlled study . Setting : Italy . Subjects : Two hundred and sixty-seven formula-fed infants , aged less than 4 months , with infantile colic , were r and omized to receive either the new infant formula ( study treatment ( ST ) ) or a st and ard formula and simethicone ( 6 mg/kg twice a day ) ( control treatment ( CT ) ) . A question naire was given to parents to evaluate for 14 days the daily number of colic episodes and crying time . Results : Out of the 199 infants who completed the study , 96 were treated with the new formula and 103 were not treated . Infants receiving the new formula had a significant decrease in colic episodes after 1 week ( 2.47±1.94 at day 7 vs 5.99±1.84 at the study entry ) compared to infants receiving the CT ( 3.72±1.98 at day 7 vs 5.41±1.88 at the study entry ) ( P<0.0001 ) . Also at day 14 , the crying episodes were significantly different between the two groups of infants ( 1.76±1.60 in ST vs 3.32±2.06 in CT ) ( P<0.0001 ) . Conclusions : The use of a partially hydrolysed formula supplemented with fructo- and galacto-OS induces a reduction of crying episodes in infants with colic after 7 and 14 days when compared with a st and ard formula and simethicone . Sponsorship : The study was supported by funds from Numico , Italy This study found that two casein hydrolysate formulas varying in composition were equally effective in managing  colicky symptoms associated with protein sensitivity . Both hydrolysate formulas were associated with a significant , comparable reduction in crying duration and intensity from baseline in 15 of 22 infants with complete data . Subsequent challenge data suggest that the population studied were infants experiencing colicky symptoms due to protein sensitivity . A greater proportion of infants showed a positive reaction ( ≥1.5h of crying/d ) to the protein challenges than the placebo challenge , and crying was rated as more intense during whey and milk protein challenges OBJECTIVE To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherl and s. STUDY DESIGN R and omized , double-blind , parallel trial with a 1-week qualification period and a 1-week intervention period . Participants . Forty-three healthy , thriving , formula-fed infants , < 6 months old , crying > 3 hours per day on at least 3 days per week . Infants were r and omized to whey hydrolysate formula ( n = 23 ) or st and ard formula ( n = 20 ) . MAIN OUTCOME MEASURE Difference in duration of crying ( minutes per day ) between qualification week and intervention week . RESULTS Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [ 95 % confidence interval : 1 - 127 minutes per day ] in favor of the whey hydrolysate formula .  Five infants did not complete the trial . The scope of the study was not sufficient to expect significant differences in the subgroup analyses . CONCLUSIONS An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting Treating the infant colic syndrome by counseling the  parents  concerning more effective responses to the infant crying is compared to the elimination of soy or cow 's milk protein from the infant 's diet in a r and omized clinical trial . Because symptoms of vomiting and diarrhea are not part of the infant colic syndrome , infants with these 
    Output:
    
agent
In breastfed infants , evidence suggests that a hypoallergenic maternal diet may be beneficial for reducing symptoms of colic .
In formula-fed infants , colic may improve after changing from a st and ard cow ’s milk formula to either a hydrolysed protein formula or a soy-based formula .
Fibre-supplemented formulae had no effect .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background . There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants . Methods . A r and omized , controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic . In the active arm , mothers excluded cow 's milk , eggs , peanuts , tree nuts , wheat , soy , and fish from their diet ; mothers in the control group continued to consume these foods . Outcomes were assessed after 7 days , as the change in cry/fuss duration over 48 hours , with vali date d charts . The primary end point was a reduction in cry/fuss duration of ≥25 % from baseline . Mothers also assessed the responses to diet with categorical and visual analog scales . Results . Of 107 infants , 90 completed the trial ( mean age : 5.7 weeks ; range : 2.9–8.6 weeks ; 54 male infants ) . Infants in both groups presented with significant distress ( geometric mean : low-allergen group : 690 minutes per 48 hours ; control group : 631 minutes per 48 hours ) . In follow-up assessment s on days 8 and 9 , there were significantly more responders in the low-allergen group ( 74 % vs 37 % ) , ie , an absolute risk reduction of 37 % ( 95 % confidence interval : 18–56 % ) . Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group ; the adjusted geometric mean ratio was 0.79 ( 95 % confidence interval : 0.63–0.97 ) , ie , an average reduction of 21 % ( 95 % confidence interval : 3–37 % ) . Mothers ' subjective assessment s of the responses to diet indicated little difference between the groups . Conclusion . Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life Because infants with colic appear to have  abdominal pain  similar to that of adults with irritable bowel syndrome , who may benefit from the addition of fiber to their diet , we tested whether fiber added to infant formula would alleviate colic .  Twenty-seven normal , term infants ( aged 2 to 8 weeks ; 14 girls ) with colic , defined as crying plus fussing for more than 3 hours a day for at least 3 days of a 6-day baseline period , were enrolled . Infants were r and omly assigned in 9-day periods to a sequence of placebo ( Isomil formula ) followed by fiber-supplemented formula ( Isomil plus soy polysaccharide ) ( n = 12 ) or the reverse ( n = 15 ) . Daily diaries of crying , fussing , sleeping , formula , intake , and stooling were kept . Twenty-two infants completed three lactulose breath hydrogen tests at the end of the baseline period and after each study period . The crossover trial was followed by 30 to 35 days of use of the study formula chosen by the parents as most beneficial but unknown to the investigators . Growth was monitored throughout . Serum cholesterol , calcium , phosphate , albumin , iron , and zinc concentrations were measured at the conclusion . There were no significant differences in average daily time spent by the infants in fussing and crying during ingestion of the fiber-supplemented formula . However , parents of 18 of 27 infants chose fiber-supplemented formula as most beneficial in ameliorating symptoms of colic . While the infants were consuming fiber-supplemented formula , stool frequency increased , and breath hydrogen excretion increased significantly , in response to lactulose . Growth and serum biochemical measurements were normal in all infants . Supplementation of infant formula with the level of soy polysaccharide used in this study may have reduced crying and fussing in some infants but did not affect colicky behavior in the majority of infants , who continued to cry and fuss excessively AIM AND OBJECTIVE The aim of the study was to evaluate the effectiveness of massage , sucrose solution , herbal tea or hydrolysed formula , each used individually in the treatment of infantile colic . BACKGROUND The term colic describes a group of symptoms that occur frequently in infants , consisting of paroxysmal abdominal pain and severe crying . Infant colic is of importance for both parents and the community health services that provide families with care , and is therefore an important clinical problem that is amenable to nursing interventions . DESIGN This prospect i ve and r and omised-controlled study involved 175 infants in Turkey . METHODS Data were gathered by using Wessel criteria ; parents wrote a daily structured diary , recording the onset and duration of crying . Patients were assigned r and omly into four different intervention groups ( massage , sucrose solution , herbal tea and hydrolysed formula ) and control group .  Duration of crying following each intervention was recorded in the diary by parents for a one week period . RESULTS There was a significant reduction in crying hours per day in all intervention groups . The difference between mean duration of total crying ( hours/day ) before and after the intervention infants in hydrolysed formula group was found higher than massage , sucrose and herbal tea group . The difference between mean duration of total crying(hours/day ) before and after the intervention infants in massage group was found lower than other intervention groups and all groups . CONCLUSION Our findings demonstrated that varied interventions such as administration of massage , sucrose solution , herbal tea and hydrolysed formula are effective in the treatment of colic . The difference between mean duration of total crying ( hours/day ) before and after the intervention in hydrolysed formula group was found higher than other intervention groups . Hydrolysed formula was the most effective in reducing the duration of crying ( hours/day ) when compared with the other intervention groups . Massage intervention yielded the least symptomatic improvement among all the interventions . RELEVANCE TO CLINICAL PRACTICE Colic treatment models used in this study can be used by nurses in neonatal and primary healthcare setting s as an aid to families for the treatment of infantile colic We evaluated the effect of an herbal tea preparation on  infantile colic  in a prospect i ve double-blind study . The use of tea eliminated the colic in 19 ( 57 % ) of 33 infants , whereas placebo was helpful in only 9 ( 26 % ) of 35 ( p < 0.01 ) . The mean colic score was significantly improved in tea-treated infants . No significant differences were noted between groups regarding number of night wakings The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change This study investigated the effect of changing the formulas of colicky infants and addressed the method ologic flaws of earlier studies . Attention was paid to issues of design ing a blind study , providing a washout period , and measuring and reproducing the effect . In this r and omized , double-blind trial , three changes of formula were made : for each of four 4-day periods , colicky infants alternately received a casein hydrolysate formula ( Nutramigen ) and a formula containing cow milk . Mothers recorded crying in diaries and indicated which crying episodes they considered to have been caused by colic . Nine infants were started on Nutramigen and eight on the cow milk formula .  With the first formula change there was significantly less crying and colic in infants when they were fed Nutramigen than when they were fed cow milk ( p less than 0.01 ) ; with the second change there was less colic when infants were fed Nutramigen ( p less than 0.05 ) but not significantly less crying . By the third change there were no significant differences between formulas . Further analyses demonstrated that there were more clinical ly meaningful positive responses ( a change in crying by at least one third ) to Nutramigen than to cow milk ( p less than 0.05 ) . However , only one subject had a clinical ly meaningful response in colic to all three formula changes . These results demonstrate that in some instances , colic improves with elimination of cow milk formula . However , the effect diminishes with time , and only infrequently is the effect reproducible This study examined 120 infants , aged 3–12 weeks , with severe colics and compared the results of a specific hypoallergenic diet ( group A ) with those of pharmacological treatment ( group B ) . Non‐breastfed group A infants  received soy milk and if unresponsive , hydrolyzed milk formulas ;  mothers of breast‐fed infants  received a diet without cow 's milk , eggs or fish .  Breast‐fed and non‐breast‐fed group B infants received dicyclomine hydrochloride 3 mg/kg/day . Results , based on quantitative measurements of crying . indicated that in breast‐fed infants there was no significant improvement between group A ( 62.5 % ) and group B ( 66.6 % ) infants . Among formula‐fed infants , comparison of positive results using soy milk ( 65.9 % ) with positive results using dicyclomine ( 53.3 % ) was not significant ; positive results using soy milk and hydrolyzed milk formulas in non‐responders to soy milk , provided an improvement in 95.4 % of cases . Pharmacological treatment provided an improvement in 53.3 % ) of cases . The diffcrence was significant ( p<0.01 ) Objectives : The aim of this study was to evaluate the efficacy on crying episodes owing to infantile colic of a new infant formula containing partially hydrolysed whey proteins , prebiotic oligosaccharides ( OS ) , with a high β-palmitic acid content . Design : Prospect i ve r and omized controlled study . Setting : Italy . Subjects : Two hundred and sixty-seven formula-fed infants , aged less than 4 months , with infantile colic , were r and omized to receive either the new infant formula ( study treatment ( ST ) ) or a st and ard formula and simethicone ( 6 mg/kg twice a day ) ( control treatment ( CT ) ) . A question naire was given to parents to evaluate for 14 days the daily number of colic episodes and crying time . Results : Out of the 199 infants who completed the study , 96 were treated with the new formula and 103 were not treated . Infants receiving the new formula had a significant decrease in colic episodes after 1 week ( 2.47±1.94 at day 7 vs 5.99±1.84 at the study entry ) compared to infants receiving the CT ( 3.72±1.98 at day 7 vs 5.41±1.88 at the study entry ) ( P<0.0001 ) . Also at day 14 , the crying episodes were significantly different between the two groups of infants ( 1.76±1.60 in ST vs 3.32±2.06 in CT ) ( P<0.0001 ) . Conclusions : The use of a partially hydrolysed formula supplemented with fructo- and galacto-OS induces a reduction of crying episodes in infants with colic after 7 and 14 days when compared with a st and ard formula and simethicone . Sponsorship : The study was supported by funds from Numico , Italy This study found that two casein hydrolysate formulas varying in composition were equally effective in managing  colicky symptoms associated with protein sensitivity . Both hydrolysate formulas were associated with a significant , comparable reduction in crying duration and intensity from baseline in 15 of 22 infants with complete data . Subsequent challenge data suggest that the population studied were infants experiencing colicky symptoms due to protein sensitivity . A greater proportion of infants showed a positive reaction ( ≥1.5h of crying/d ) to the protein challenges than the placebo challenge , and crying was rated as more intense during whey and milk protein challenges OBJECTIVE To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherl and s. STUDY DESIGN R and omized , double-blind , parallel trial with a 1-week qualification period and a 1-week intervention period . Participants . Forty-three healthy , thriving , formula-fed infants , < 6 months old , crying > 3 hours per day on at least 3 days per week . Infants were r and omized to whey hydrolysate formula ( n = 23 ) or st and ard formula ( n = 20 ) . MAIN OUTCOME MEASURE Difference in duration of crying ( minutes per day ) between qualification week and intervention week . RESULTS Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [ 95 % confidence interval : 1 - 127 minutes per day ] in favor of the whey hydrolysate formula .  Five infants did not complete the trial . The scope of the study was not sufficient to expect significant differences in the subgroup analyses . CONCLUSIONS An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting Treating the infant colic syndrome by counseling the  parents  concerning more effective responses to the infant crying is compared to the elimination of soy or cow 's milk protein from the infant 's diet in a r and omized clinical trial . Because symptoms of vomiting and diarrhea are not part of the infant colic syndrome , infants with these 
    Output:
    